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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 K133809
Device Name OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
Applicant
OXFORD PERFORMANCE MATERIALS
30 South Satellite Road
South Windsor,  CT  06074
Applicant Contact LEIGH AYRES
Correspondent
OXFORD PERFORMANCE MATERIALS
30 South Satellite Road
South Windsor,  CT  06074
Correspondent Contact LEIGH AYRES
Regulation Number878.3500
Classification Product Code
KKY  
Date Received12/16/2013
Decision Date 07/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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