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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sensing, Optical Contour
510(k) Number K232023
Device Name Momentum Spine
Applicant
Momentum Health, Inc.
2727 Rue St-Patrick, Apt.109
Montreal,  CA H3K0A8
Applicant Contact Evan Dimentberg
Correspondent
Momentum Health, Inc.
2727 Rue St-Patrick, Apt.109
Montreal,  CA H3K0A8
Correspondent Contact Evan Dimentberg
Classification Product Code
LDK  
Date Received07/07/2023
Decision Date 10/04/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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