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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 K160988
Device Name Biopor, AOC Porous Polyethylene, Cerepor
Applicant
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Applicant Contact CHELSEA MITCHELL
Correspondent
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Correspondent Contact CHELSEA MITCHELL
Regulation Number878.3500
Classification Product Code
KKY  
Date Received04/08/2016
Decision Date 07/14/2016
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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