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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 K121360
Device Name BIODESIGN ENT REPAIR GRAFT
Applicant
Cook Biotech Incorprated
1425 Innovation Place
West Lafayette,  IN  47906 -1000
Applicant Contact MARY A FADERAN, PH.D., RAC
Correspondent
Cook Biotech Incorprated
1425 Innovation Place
West Lafayette,  IN  47906 -1000
Correspondent Contact MARY A FADERAN, PH.D., RAC
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received05/07/2012
Decision Date 02/27/2013
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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