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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K131015
Device Name BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
Applicant
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact MARY A FADERAN
Correspondent
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact MARY A FADERAN
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received04/11/2013
Decision Date 10/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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