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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 K022350
Device Name BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
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 Received07/19/2002
Decision Date 08/23/2002
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
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