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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 K042026
Device Name BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
Applicant
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact KAREN S GWOZDOWSKI GAUVIN
Correspondent
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Correspondent Contact KAREN S GWOZDOWSKI GAUVIN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/28/2004
Decision Date 09/10/2004
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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