Cleared Special

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

K070093 · Ceremed , Inc. · Ear, Nose, Throat
Jan 2007
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K070093 is an FDA 510(k) clearance for the OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, 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 January 24, 2007, 14 days after receiving the submission on January 10, 2007. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K070093 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2007
Decision Date January 24, 2007
Days to Decision 14 days
Submission Type Special
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

Similar Devices — KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

All 32
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
K232646 · Cook Biotech Incorporated · May 2024
Biodesign Otologic Repair Graft
K161000 · Cook Biotech Incorporated · May 2016
Biodesign Otologic Repair Graft
K150594 · Cook Biotech Incorprated · Sep 2015
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
K132198 · Ceremed , Inc. · Sep 2013
BIODESIGN ENT REPAIR GRAFT
K121360 · Cook Biotech Incorprated · Feb 2013
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561 · Ceremed , Inc. · Nov 2012