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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K150668
Device Name Biodesign Enterocutaneous Fistula Plug
Applicant
COOK BIOTECH INCORPRATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Applicant Contact Perry W Guinn
Correspondent
COOK BIOTECH INCORPRATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Correspondent Contact Nick Wang
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/16/2015
Decision Date 12/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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