Cleared Traditional

OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE

K062280 · Ceremed , Inc. · Ear, Nose, Throat
Dec 2006
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K062280 is an FDA 510(k) clearance for the OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE, a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 11, 2006, 126 days after receiving the submission on August 7, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K062280 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2006
Decision Date December 11, 2006
Days to Decision 126 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KHJ — Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620

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