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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 K083372
Device Name ARROWBONE-A, ARROWBONE-B
Applicant
BRAINBASE CORPORATION
26420 SUMMER GREENS DR.
BONITA SPRINGS,  FL  34135
Applicant Contact H. NEAL DUNNING
Correspondent
BRAINBASE CORPORATION
26420 SUMMER GREENS DR.
BONITA SPRINGS,  FL  34135
Correspondent Contact H. NEAL DUNNING
Regulation Number872.3930
Classification Product Code
LYC  
Date Received11/14/2008
Decision Date 12/08/2009
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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