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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
Canston,  RI  02920
Applicant Contact JEANNETTE G CLOUTIER
Correspondent
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  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
Predetermined Change
Control Plan Authorized		 No
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