510(k) K022665

POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE by Hohenstein Enterprises, Inc. — Product Code KKY

K022665 is an FDA 510(k) premarket notification submitted by Hohenstein Enterprises, Inc. for the device "POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE". The FDA issued a decision of Substantially Equivalent on October 9, 2002. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500.