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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K070055
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 Number872.3930
Classification Product Code
LYC  
Date Received01/04/2007
Decision Date 06/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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