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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 K063178
Device Name BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
Applicant
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact STEPHANIE BAKER
Correspondent
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Correspondent Contact STEPHANIE BAKER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received10/19/2006
Decision Date 11/21/2006
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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