AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT


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

Correspodent Contact tadeusz wellisz
Regulation Number 878.3500
Classification Product Code
KKY  
Date Received 02/25/2008
Decision Date 04/21/2008
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