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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 K021736
Device Name BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
Applicant
C.R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Applicant Contact BRAIN A KANERVIKO
Correspondent
C.R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Correspondent Contact BRAIN A KANERVIKO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/28/2002
Decision Date 07/16/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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