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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K071937
Device Name BONALIVE GRANULES AND BONALIVE PLATES
Applicant
Vivoxid , Ltd.
6470 Riverview Ter.
Findley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Vivoxid , Ltd.
6470 Riverview Ter.
Findley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number878.3500
Classification Product Code
KKY  
Date Received07/13/2007
Decision Date 10/19/2007
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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