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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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AMICUS Separator System; ALYX Component System

Applicant:Fenwal, Inc
510(k) number:BK120041
Product:AMICUS Separator System; ALYX Component System
Date: 10/4/2012

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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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