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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Spectra Optia Apheresis System

Applicant:Terumo BCT, Inc
510(k) number:BK120076
Product:Spectra Optia® Apheresis System
Date: 02/26/2013


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002