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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 K971745
Device Name BARD COMPOSITE PROSTHESIS
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact JEANNETTE G CLOUTIER
Correspondent
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Correspondent Contact JEANNETTE G CLOUTIER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/12/1997
Decision Date 08/06/1997
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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