21CFR1040.10-2009 国外国际规范.pdf

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Pt. 1040 21 CFR Ch. I (4–1–09 Edition) that the microwave oven model for are applicable as specified to all laser which the exemption is sought should products manufactured or assembled continue to comply with paragraphs (c) after August 1, 1976, except when: (1), (2), and (3) of this section under the (1) Such a laser product is either sold adverse condition of use addressed by to a manufacturer of an electronic such precautionary statement(s). An product for use as a component (or re- original and two copies of applications placement) in such electronic product, shall be submitted to the Division of or Dockets Management (HFA–305), Food (2) Sold by or for a manufacturer of and Drug Administration, 5630 Fishers an electronic product for use as a com- Lane, rm. 1061, Rockville, MD 20852. ponent (or replacement) in such elec- Copies of the written portion of the ap- tronic product, provided that such plication, including supporting data laser product: and information, and the Director’s ac- (i) Is accompanied by a

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