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510(k) SUMMARY for (k082965510(K) Summary of Safety and Effectiveness.(Per 21 CFR 807.92) 2.1. General Information Establishment Date Prepared:*Manufacturer:*Address:*Owner Number:9099902×Contact
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What is ii 510k summary of?
The 510k summary provides a brief overview of a medical device submitted for FDA clearance.
Who is required to file ii 510k summary of?
Manufacturers of medical devices seeking FDA clearance through the 510k process are required to file a summary.
How to fill out ii 510k summary of?
The summary should include key information such as device description, intended use, technological characteristics, and performance data.
What is the purpose of ii 510k summary of?
The purpose of the 510k summary is to provide a concise overview of the device to the FDA, facilitating the clearance process.
What information must be reported on ii 510k summary of?
The summary should contain device description, indications for use, technological characteristics, performance data, and comparisons to predicate devices.
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