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FDA 510(k) Application Details - K210632
Device Classification Name
More FDA Info for this Device
510(K) Number
K210632
Device Name
Contour ProtegeAI
Applicant
MIM Software Inc.
25800 Science Park Drive - Suite 180
Cleveland, OH 44122 US
Other 510(k) Applications for this Company
Contact
Lynn Hanigan
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2021
Decision Date
10/20/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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