POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE


Device Classification Name

material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction

510(k) Number K022665
Device Name POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
Original Applicant
HOHENSTEIN ENTERPRISES, INC.
731 1/2 north labrea ave.
los angeles, 
CA 
90038

Original Contact l. franklin bost
Regulation Number 878.3500
Classification Product Code
KKY  
Date Received 08/09/2002
Decision Date 10/09/2002
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