Cleared Traditional

BIOPOR AOC POROUS POLYETHYLENE, CEREPOR

K141880 · Ceremed , Inc. · General & Plastic Surgery

Apr 2015

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K141880 is an FDA 510(k) clearance for the BIOPOR AOC POROUS POLYETHYLENE, 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 April 16, 2015, 279 days after receiving the submission on July 11, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.

Submission Details

510(k) Number	K141880 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2014
Decision Date	April 16, 2015
Days to Decision	279 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