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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 K051879
Device Name SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact KATHY ANDERSON
Correspondent
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact KATHY ANDERSON
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
FTL   GWO  
Date Received07/11/2005
Decision Date 10/05/2005
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
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