Cleared Traditional

AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV

K082245 · Ceremed , Inc. · Ear, Nose, Throat
Sep 2008
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K082245 is an FDA 510(k) clearance for the AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV, 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 September 18, 2008, 42 days after receiving the submission on August 7, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K082245 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2008
Decision Date September 18, 2008
Days to Decision 42 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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