Cleared Traditional

BIODESIGN ENT REPAIR GRAFT

K121360 · Cook Biotech Incorprated · Ear, Nose, Throat
Feb 2013
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K121360 is an FDA 510(k) clearance for the BIODESIGN ENT REPAIR GRAFT, a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Cook Biotech Incorprated (West Lafayette, US). The FDA issued a Cleared decision on February 27, 2013, 296 days after receiving the submission on May 7, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K121360 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2012
Decision Date February 27, 2013
Days to Decision 296 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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