
Get the free UrgoClean Ag 510k Parts 4513 Cover Letter revised July Aug 2015 V3.pdf
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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
August 7, 2015,
Laboratories
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What is urgoclean ag 510k parts?
Urgoclean ag 510k parts are components of a medical device that require premarket notification to the FDA.
Who is required to file urgoclean ag 510k parts?
Manufacturers who intend to market medical devices in the United States are required to file urgoclean ag 510k parts.
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Urgoclean ag 510k parts must be filled out following the FDA guidelines for premarket notification submission.
What is the purpose of urgoclean ag 510k parts?
The purpose of urgoclean ag 510k parts is to demonstrate that the medical device is substantially equivalent to a legally marketed device.
What information must be reported on urgoclean ag 510k parts?
Information such as the device description, indications for use, materials, and performance testing data must be reported on urgoclean ag 510k parts.
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