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510(k) Summary SE Thornier Inc. Myofiber Suture Date prepared: September 13, 2012, Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92 1) Device name Trade name: Myofiber Suture
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How to fill out 510k 722 - food
How to fill out 510k 722 - food:
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What is 510k 722 - food?
510k 722 - food is a premarket notification submitted to the FDA for certain food related products.
Who is required to file 510k 722 - food?
Manufacturers, importers, and distributors of certain food related products are required to file 510k 722 with the FDA.
How to fill out 510k 722 - food?
To fill out 510k 722 - food, companies must provide detailed information about the product, its intended use, and any similarities to existing products.
What is the purpose of 510k 722 - food?
The purpose of 510k 722 - food is to demonstrate that certain food related products are safe and effective for their intended use before they are marketed in the US.
What information must be reported on 510k 722 - food?
Information such as product composition, design, performance data, and any known safety risks must be reported on 510k 722 for food related products.
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