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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 K061754
Device Name BARD COMPOSITE L/P MESH
Applicant
DAVOL INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
cranston,  RI  02920
Applicant Contact gail dow
Correspondent
DAVOL INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
cranston,  RI  02920
Correspondent Contact gail dow
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/21/2006
Decision Date 10/23/2006
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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