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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
"__________________________________" (Name of manufacturer or seller) hereby guarantees that the articles listed herein are impact-resistant within the meaning of 21 CFR 801.410 and have been tested pursuant to that section. Impact-resistant lenses are not unbreakable or shatterproof. Records of testing will be maintained for a period of three (3) years from the date of shipment, and copies will be forwarded to FDA upon request.
(Signature and street address of manufacturer or seller)
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Updated 4/5/2001
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Center for Devices and Radiological Health / CDRH