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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K101866
Device Name CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
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
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/02/2010
Decision Date 07/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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