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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 K061892
Device Name PROPATCH SOFT TISSUE REPAIR MATRIX
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
Correspodent Contact john d ferros
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE   OXH  
Date Received07/03/2006
Decision Date 11/22/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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