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FDA 510(k) Application Details - K221195
Device Classification Name
More FDA Info for this Device
510(K) Number
K221195
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
04/25/2022
Decision Date
06/28/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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