Biodesign Otologic Repair Graft— 510(k) K150594

Name: FDA 510(k) clearance K150594
Creator: U.S. Food and Drug Administration
Published: 2015-09-16

Substantially Equivalent

Cook Biotech Incorprated

FDA 510(k) clearance K150594 for Biodesign Otologic Repair Graft, Substantially Equivalent on 2015-09-16. 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: 2015-03-09
Decision date: 2015-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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