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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 K052322
Device Name BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
Applicant
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact ROBIN DRAGO
Correspondent
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Correspondent Contact ROBIN DRAGO
Regulation Number878.3300
Classification Product Code
FTM  
Date Received08/25/2005
Decision Date 04/10/2006
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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