BIODESIGN ENT REPAIR GRAFT— 510(k) K121360

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.

Clearance details

Applicant: Cook Biotech Incorprated
Product code: Code KHJ
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

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