Cleared Traditional

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

K043133 · Ceremed , Inc. · General & Plastic Surgery

Mar 2005

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K043133 is an FDA 510(k) clearance for the AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR, a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II — Special Controls, product code KKY), submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 2, 2005, 110 days after receiving the submission on November 12, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.

Submission Details

510(k) Number	K043133 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2004
Decision Date	March 02, 2005
Days to Decision	110 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3500