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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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Urgoclean ag 510k parts are components of a medical device that require premarket notification to the FDA.
Manufacturers who intend to market medical devices in the United States are required to file urgoclean ag 510k parts.
Urgoclean ag 510k parts must be filled out following the FDA guidelines for premarket notification submission.
The purpose of urgoclean ag 510k parts is to demonstrate that the medical device is substantially equivalent to a legally marketed device.
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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