
Get the free 07--510k Summary of Use (r4).pdf - accessdata fda
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center WO66G609
Silver Spring, MD 209930002
September 2, 2015,
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What is 07--510k summary of use?
The 07--510k summary of use is a summary of the intended use of a medical device submitted to the FDA for premarket notification.
Who is required to file 07--510k summary of use?
Manufacturers of medical devices are required to file the 07--510k summary of use when seeking premarket notification.
How to fill out 07--510k summary of use?
To fill out the 07--510k summary of use, manufacturers must provide detailed information on the intended use of the medical device, including indications for use, patient population, and any limitations or contraindications.
What is the purpose of 07--510k summary of use?
The purpose of the 07--510k summary of use is to demonstrate to the FDA that the medical device is safe and effective for its intended use.
What information must be reported on 07--510k summary of use?
The 07--510k summary of use must include information on the intended use of the medical device, indications for use, patient population, and any limitations or contraindications.
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