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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 K102766
Device Name COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
Applicant
C.R. BARD INC
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Applicant Contact KETI SINO
Correspondent
C.R. BARD INC
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Correspondent Contact KETI SINO
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Codes
GCJ   OQL  
Date Received09/24/2010
Decision Date 12/16/2010
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
Recalls CDRH Recalls
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