BIODESIGN ENT REPAIR GRAFT— 510(k) K121360

Name: FDA 510(k) clearance K121360
Creator: U.S. Food and Drug Administration
Published: 2013-02-27

Substantially Equivalent

Cook Biotech Incorprated

FDA 510(k) clearance K121360 for BIODESIGN ENT REPAIR GRAFT, Substantially Equivalent on 2013-02-27. Applicant: Cook Biotech Incorprated. Device class: 2.

Clearance details

Applicant: Cook Biotech Incorprated
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2012-05-07
Decision date: 2013-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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