• Title/Summary/Keyword: U-Product

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The Liability for Unsafe Medical Product and The Preemption Clause of Medical Device Act (의료기기의 결함으로 인한 손해배상책임과 미국 연방법 우선 적용 이론에 관하여)

  • Kim, Jang Han
    • The Korean Society of Law and Medicine
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    • v.15 no.2
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    • pp.63-89
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    • 2014
  • In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

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Assessment of a U Product purity from Pyroprocessing Spent EBR-II Fuel (EBR-II 사용후핵연료의 건식처리공정에 의한 우라늄의 순도 평가)

  • Lee, Jung-Won;Lee, Han-Soo;Kim, Eung-Ho;Lee, Jong-Hyeon;Vaden, D.;Westphal, B.;Simpson, M.F.
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.7 no.3
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    • pp.167-174
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    • 2009
  • A comprehensive analysis has been conducted on the purity of the uranium product generated from a pyroprocessing of EBR-II spent fuel. The analysis results were compared to the low-level waste criteria for both ROK and USA under a collaborative program between INL and KAERI. It is found that the US LLW definition does not include the activity from any U isotopes, but the Korean one does. The analysis results show that Pu-239 is the only alpha emitting isotope other than U isotopes that exceed the limit in the EBR-II U product. Pu contamination of the product seems to be drastically reduced in a preliminary test of the modified cathode process, and the further development of the proposed technology may be possible to meet the US LLW criteria.

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Study concerning the Scope of Merchandise under the U.S. Antidumping Law through Case (사례를 통한 미반덤핑법상 상품의 범위에 관한 연구)

  • Ha, Choong-Lyong;Han, Na-Hee
    • International Commerce and Information Review
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    • v.11 no.3
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    • pp.265-286
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    • 2009
  • Dumping describes the practice of international price discrimination whereby a producer or exporter sells merchandise in an export market at less than fair value. The U.S. antidumping statutory framework is embodied in the Tariff Act of 1930. The Act states that "dumping" refers to the sale or likely sale of goods at less than fair value. 19 U.S.C. $\S$ 1677(34). The Commerce Department and the Commission are jointly responsible for administering the antidumping law. Commerce determines whether foreign merchandise is being sold in the United States at less than fair value, and the Commission determines whether a domestic industry producing a product like the imported merchandise has been materially injured or threatened with material injury by reason of imports of that product. Recently, in U.S. v. Eurodif, the Supreme Court held the question whether the Commerce can reasonably determin that foreign merchandise has been sold within the meaning of the antidumping law in U.S.. Should 19 U.S.C. Section 1673, which calls for "antidumping" duties on foreign goods, but not services, that sell at less than fair value in the U.S., apply to imported low enriched uranium? Yes. In a unanimous opinion written by Justice David H. Souter, the Supreme Court held that the Commerce Department's view of imported low enriched uranium, as the sale of goods rather than services, was permissible. It reasoned that, since 19 U.S.C. Section 1673 did not specify whether it applied to the production of low enriched uranium, it was left to the reasonable interpretation of the Commerce Department to determine. Accordingly, the Court found the Commerce Department interpreted the statute reasonably.

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ON THE SPECTRAL GEOMETRY FOR THE JACOBI OPERATORS OF HARMONIC MAPS INTO PRODUCT MANIFOLDS

  • Kang, Tae-Ho;Ki, U-Hang;Pak, Jin-Suk
    • Journal of the Korean Mathematical Society
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    • v.34 no.2
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    • pp.483-500
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    • 1997
  • We investigate the geometric properties reflected by the spectra of the Jacobi operator of a harmonic map when the target manifold is a Riemannian product manifold or a Kaehlerian product manifold. And also we study the spectral characterization of Riemannian sumersions when the target manifold is $S^n \times S^n$ or $CP^n \times CP^n$.

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Hypersurfaces with quasi-integrable ( f, g, u, ʋ, λ) -structure of an odd-dimensional sphere

  • Ki, U-Hang;Cho, Jong-Ki;Lee, Sung Baik
    • Honam Mathematical Journal
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    • v.4 no.1
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    • pp.75-84
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    • 1982
  • Let M be a complete and orientable hypersurface of an odd-dimensional sphere $S^{2n+1}$ with quasi-integrable $(f,\;g,\;u,\;{\nu},\;{\lambda})$ -structure. The purpose of the present paper is to prove the following two theorems. (I) If the scalar curvature of M is constant and the function $\lambda$ is not locally constant, then M is a great sphere $S^{2n}$(1) or a product of two spheres with the same dimension $S^{n}(1/\sqrt{2}){\times}S^{n}(1/\sqrt{2})$. (II) Suppose that the sectional curvature of the section $\gamma(u,\;{\nu})$ spanned by u and $\nu$ is constant on M and M is compact. If the second fundamental tensor H of M is positive semi-definite and satisfies trace $$^{t}HH{\leq_-}{2n}$$, then M is a great sphere $S^{2n}$ (1) or a product of two spheres $S^{n}{\times}S^{n}$ or $S^{p}{\times}S^{2n-p}$, p being odd.

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A Coevolutionary Algorithm for Balancing and Sequencing Mixed - Model U-Lines (혼합모델 U 라인의 작업할당과 투입순서를 위한 공진화 알고리듬)

  • Kim, Yeo-Keun;Kim, Sun-Jin;Kim, Jae-Yun;Kwak, Jai-Seung
    • Journal of Korean Institute of Industrial Engineers
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    • v.25 no.4
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    • pp.411-420
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    • 1999
  • A mixed model production line is a production line where a variety of product models are produced. In U-shaped production lines (called U-lines) used in just-in-time production system, the strategy of mixing product models is often used to provide various types of products to customers in time. Line balancing and model sequencing problems are important for an efficient use of mixed model U-lines. Although the two problems are tightly interrelated with each other, prior researches have considered them separately or sequentially. This paper presents a new method using a coevolutionary algorithm that can solve the two problems at the same time. To promote diversity and search efficiency, in this paper the evolutionary system is based on the localized interactions within and between populations. Methods of selecting environmental individuals and evaluating fitness are developed. Efficient genetic representations and operator schemes are also provided. When designing the schemes, we take into account the features specific to the problems. The experimental results demonstrate that the proposed algorithm is superior to existing approaches.

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The Brand Name Effect of Consumer's Evaluation on Intrinsic Attributes :A Case Study of Clothing Market

  • Bae, Mi-Kyeong;Lee, Seung-Sin;Park, Sun-Young
    • International Journal of Human Ecology
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    • v.4 no.1
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    • pp.45-54
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    • 2003
  • The purpose of this study was primarily to examine various variables influencing consumer purchasing behavior on perceived product quality, value toward product including brand loyalty, price, consumer's willingness to pay for the product, and their expenditure patterns in Korean apparel market. Factor analysis was used to evaluate the credibility of dependent variables, and T-test was used to compare the effect of brand label, country of origin, brand effect between Korean and U.S, and jacket price and quality on consumer characteristics. Discriminated analysis was used to find the effective variables influencing the two reference group differences when they evaluated Korean and U.S. labeled and non-labeled apparel products. Multiple Regression analysis was used to examine the effects of consumer characteristics on perceived quality, perceived value, perceived price, and their willingness to buy. The results of this study also provides useful information of consumer purchasing behavior on U.S. branded apparel which may or already launched the Korean fashion merchandizing market.

Benefits Sought and Knitwear Purchasing Behavior of Female College Students in the U.S. (미국 여대생의 의복 추구 혜택과 니트웨어 구매 행동)

  • Lee, Ok Hee
    • The Research Journal of the Costume Culture
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    • v.14 no.4
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    • pp.542-555
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    • 2006
  • The main objective of this study was to investigate the relationship between benefits segmentation and knitwear purchasing behavior of college female students in the U.S. The questionnaires for this survey were developed to measure knitwear purchasing behavior and benefits segmentation. The questionnaire was administered to 119 female college students in the University of California. The data was analyzed by percentage, frequency, mean, factor analysis, Cluster Analysis and ANOVA, Duncan Multiple Range test. The female college students in the U.S. were classified into fourth subdivisions by the cluster analysis. In the case of fashion information sources of knit wear, significant differences were found according to benefits sought subdivision in observation of famous people's clothing, fashion articles in magazines and newspapers, TV advertisements, Newspaper advertisements, advice of salespeople, and Catalogs. The evaluation criteria of knit wear product of consumers were significantly different depending on benefits sought subdivision in design/style, quality of construction, fashionable, brand and store name, pleasing to others, prestige, and sexy. The store attributes of knitwear product of consumers were significantly different depending on benefits sought subdivision in friendliness of sales personnel, product knowledge of sales personnel, brand names, new fashion, and variety of products. The outlook for the industry of knitwear look to remain bright, there should be a continuous effort to research and invest in consumer satisfaction of knitwear.

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