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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 K122436
Device Name COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST 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 Received08/10/2012
Decision Date 11/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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