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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K103010
Device Name STRYKER PATIENT SPECIFIC POLYMER IMPLANT
Applicant
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact STEPHANIE FITTS
Correspondent
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact STEPHANIE FITTS
Regulation Number878.3500
Classification Product Code
KKY  
Subsequent Product Code
GWO  
Date Received10/12/2010
Decision Date 10/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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