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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 K081010
FOIA Releasable 510(k) K081010
Device Name BARD 3DMAX MESH
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Applicant Contact STEPHANIE BAKER
Correspondent
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Correspondent Contact STEPHANIE BAKER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/09/2008
Decision Date 10/07/2008
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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