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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 S Satellite Rd.
South Windsor,  CT  06074
Applicant Contact LEIGH AYRES
Correspondent
Oxford Performance Materials
30 S Satellite Rd.
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 & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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