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Vaccines, Blood & Biologics

June 5, 2009 Rescind Letter

June 5, 2009

U.S. Department of Defense
Attention:  George Magee, Ph.D.
Office of the Assistant Secretary of Defense Health Affairs
Skyline Five, Suite 810
5111 Leesburg Pike
Falls Church, VA 22041-3206

Re: BK960004/0
Product: Defense Blood Standard System (DBSS), version 1.0/1.03
Dated: January 13, 2009
Received: January 28, 2009

Dear Dr. Magee:

Pursuant to your request for voluntary withdrawal dated January 13, 2009, regarding the above referenced Premarket Notification (510(k)) submission by the U.S. Department of Defense, the Office of Blood Research and Review acknowledges your letter and rescinds its determination of substantial equivalence of August 1, 1997, for the above referenced device.  This specific device, submitted under BK960004, can no longer be marketed in the United States without a new order allowing you to do so.  In addition, it can not serve as a predicate device for purposes of determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, for any other devices that may be submitted for review or are currently under review for a determination of substantial equivalence.

If you have any questions regarding this letter, please contact Heather Erdman, Regulatory Project Manager, at (301) 827-6182.

Sincerely yours,

-- signature --

Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research

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