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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K110581
Device Name PROPATCH SOFT TISSUE REPAIR MATRIX
Applicant
Cryolife, Inc.
1655 Roberts Blvd., NW
Kennesaw,  GA  30144
Applicant Contact BRYAN BROSSEAU
Correspondent
Cryolife, Inc.
1655 Roberts Blvd., NW
Kennesaw,  GA  30144
Correspondent Contact BRYAN BROSSEAU
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/01/2011
Decision Date 01/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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