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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Substantially Equivalent 510(k) Device Information

The following products are regulated as 510(k)s: Devices used by the blood banking industry including blood establishment computer software, transfer devices, collection systems, separators, culture bottles, fluid warmers, etc.

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Related Information

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Approvals & Clearances

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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