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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, polymeric
510(k) Number K024008
Device Name SMALL BARD VENTRALEX PATCH
Applicant
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact BRIAN A KANERVIKO
Correspondent
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Correspondent Contact BRIAN A KANERVIKO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/04/2002
Decision Date 02/20/2003
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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