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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 K230463
Device Name NSite Scoliosis Assessment App
Applicant
Nsite, Inc.
821 Stanford Ave.
Menlo Park,  CA  94025
Applicant Contact Michael J. Gardner
Correspondent
Nsite, Inc.
821 Stanford Ave.
Menlo Park,  CA  94025
Correspondent Contact Michael J. Gardner
Classification Product Code
LDK  
Date Received02/21/2023
Decision Date 11/15/2023
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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