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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 K080507
Device Name AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
Applicant
CEREMED, INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016
Applicant Contact TADEUSZ WELLISZ
Correspondent
CEREMED, INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016
Correspondent Contact TADEUSZ WELLISZ
Regulation Number878.3500
Classification Product Code
KKY  
Date Received02/25/2008
Decision Date 04/21/2008
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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