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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 K062729
Device Name SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
Applicant
COOK BIOTECH, INC.
1400 CUMBERLAND AVE.
WEST LAFAYETTE,  IN  47906
Applicant Contact DANIEL J DILLON
Correspondent
COOK BIOTECH, INC.
1400 CUMBERLAND AVE.
WEST LAFAYETTE,  IN  47906
Correspondent Contact DANIEL J DILLON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/13/2006
Decision Date 10/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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