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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 K092021
Device Name CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
Applicant
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW,  GA  30144
Applicant Contact JOHN D FERROS
Correspondent
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW,  GA  30144
Correspondent Contact JOHN D FERROS
Classification Product Code
OHA  
Date Received07/06/2009
Decision Date 05/25/2010
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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