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FDA 510(k) Application Details - K232023
Device Classification Name
Device, Sensing, Optical Contour
More FDA Info for this Device
510(K) Number
K232023
Device Name
Device, Sensing, Optical Contour
Applicant
Momentum Health Inc.
2727 Rue St-Patrick, Apt 109
Montreal H3K0A8 CA
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Contact
Evan Dimentberg
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LDK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/07/2023
Decision Date
10/04/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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