Cleared Traditional

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

K080507 · Ceremed , Inc. · General & Plastic Surgery

Apr 2008

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K080507 is an FDA 510(k) clearance for the AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, 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 April 21, 2008, 56 days after receiving the submission on February 25, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.

Submission Details

510(k) Number	K080507 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2008
Decision Date	April 21, 2008
Days to Decision	56 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