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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 TERRACE
FRIDLEY,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
VIVOXID LTD.
6470 RIVERVIEW TERRACE
FRIDLEY,  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 Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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