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FDA 510(k) Application Details - DEN210013
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN210013
Device Name
OsteoProbe
Applicant
Active Life Scientific, Inc.
1027 Garden Street
Santa Barbara, CA 93101 US
Other 510(k) Applications for this Company
Contact
Alexander Proctor
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QGQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2021
Decision Date
08/19/2021
Decision
DENG -
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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