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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
510(k) Number K150594
Device Name Biodesign Otologic Repair Graft
Applicant
Cook Biotech Incorprated
1425 Innovation Place
West Lafayetta,  IN  47906
Applicant Contact PERRY W. GUINN
Correspondent
Cook Biotech Incorprated
1425 Innovation Place
West Lafayetta,  IN  47906
Correspondent Contact Katie Molland
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received03/09/2015
Decision Date 09/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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