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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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HCLL™ Donor, version 2.0

Applicant:Mediware Information Systems, Inc
510(k) number:BK080061
Product:HCLLTM Donor, version 2.0
Date: 12/02/2008

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