Cleared Traditional

Biodesign Otologic Repair Graft

K150594 · Cook Biotech Incorprated · Ear, Nose, Throat
Sep 2015
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K150594 is an FDA 510(k) clearance for the Biodesign Otologic Repair Graft, a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Cook Biotech Incorprated (West Lafayetta, US). The FDA issued a Cleared decision on September 16, 2015, 191 days after receiving the submission on March 9, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K150594 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date September 16, 2015
Days to Decision 191 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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