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FDA 510(k) Application Details - K033484
Device Classification Name
Heart Valve, More Than Minimally Manipulated Allograft
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510(K) Number
K033484
Device Name
Heart Valve, More Than Minimally Manipulated Allograft
Applicant
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW, GA 30144 US
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Contact
DAVID M FRONK
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Regulation Number
000.0000
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Classification Product Code
OHA
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More FDA Info for this Product Code
Date Received
11/04/2003
Decision Date
02/07/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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