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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name heart valve, more than minimally manipulated allograft
510(k) Number K033484
Device Name HUMAN HEART VALVE, CRYOVALVE SG
Applicant
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW,  GA  30144
Applicant Contact DAVID M FRONK
Correspondent
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW,  GA  30144
Correspondent Contact DAVID M FRONK
Classification Product Code
OHA  
Date Received11/04/2003
Decision Date 02/07/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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