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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name bone indentation device
De Novo Number DEN210013
Device Name OsteoProbe
Requester
Active Life Scientific, Inc.
1027 garden street
santa barbara,  CA  93101
Contact alexander proctor
Regulation Number888.1600
Classification Product Code
QGQ  
Date Received03/30/2021
Decision Date 08/19/2021
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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