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K13 1993 510(k) Summary Multi chem U 1.0 CRT Submitter and Contact: Paula McCarthy Stephanie Garth Head of Quality and Regulatory Affairs Techno path Fort Henry Business Park Balling, Co. Tipperary
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What is 510k summary multichem u?
510k summary multichem u is a summary of the information required for premarket notification submission for certain medical devices.
Who is required to file 510k summary multichem u?
Manufacturers of medical devices seeking market approval from the FDA are required to file 510k summary multichem u.
How to fill out 510k summary multichem u?
You can fill out 510k summary multichem u by providing detailed information about the medical device, its intended use, performance data, and comparisons to similar devices already on the market.
What is the purpose of 510k summary multichem u?
The purpose of 510k summary multichem u is to demonstrate the substantial equivalence of a new medical device to a legally marketed device, in order to obtain FDA clearance for marketing.
What information must be reported on 510k summary multichem u?
Information such as device description, intended use, technological characteristics, performance data, labeling, and biocompatibility must be reported on 510k summary multichem u.
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