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510k Premarket Notification 92) /00V3 FIXES SCREWS SEMIMETAL TECHNOLOGIES SECTION 5: 510(K) SUMMARY MAR 2 I 2007 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92 Submitter
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Summary - accessdata FDA is a report required by the FDA to provide a concise overview of a product's safety and effectiveness.
Manufacturers or sponsors of FDA-regulated products are required to file summary - accessdata FDA.
Summary - accessdata FDA can be filled out online through the FDA's electronic submission system.
The purpose of summary - accessdata FDA is to provide the FDA with a quick snapshot of a product's safety and effectiveness.
Information such as product details, safety data, effectiveness data, and adverse events must be reported on summary - accessdata FDA.
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