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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 K161052
Device Name OsteoFab Patient Specific Facial Device
Applicant
OXFORD PERFORMANCE MATERIALS, INC.
30 S Satellite Road
South Windsor,  CT  06074
Applicant Contact Leigh Ayres
Correspondent
OXFORD PERFORMANCE MATERIALS, INC.
30 S Satellite Road
South Windsor,  CT  06074
Correspondent Contact Leigh Ayres
Regulation Number878.3500
Classification Product Code
KKY  
Date Received04/14/2016
Decision Date 07/20/2016
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
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