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U.S. Department of Health and Human Services

Medical Devices

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Premarket Submissions

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Contact FDA

1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)

Office of Communication, Education and Radiation Programs

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

WO66-4621

Silver Spring, MD 20993
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