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510(k) Summary (21 CFR 807.92)
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MAY 1 7 2MT
510(k) Number: K 13 0659
Submission Owners:
Official Correspondent:
Date Prepared:
Trade Name:
Common Name:
Classification Name:
Regulation
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What is 510k summary 21 cfr?
The 510k summary 21 CFR is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a device already on the market.
Who is required to file 510k summary 21 cfr?
Manufacturers of medical devices seeking FDA clearance to market their products in the United States are required to file a 510k summary 21 CFR.
How to fill out 510k summary 21 cfr?
To fill out a 510k summary 21 CFR, manufacturers need to provide detailed information about their device, compare it to a predicate device, and demonstrate substantial equivalence.
What is the purpose of 510k summary 21 cfr?
The purpose of a 510k summary 21 CFR is to provide the FDA with information to determine if a new medical device is safe and effective for use in the market.
What information must be reported on 510k summary 21 cfr?
The information that must be reported on a 510k summary 21 CFR includes device description, indications for use, technological characteristics, and performance data.
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