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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K242417
Device Name VECTR – Video Endoscopic Carpal Tunnel Release System
Applicant
Rafael Medical Devices, LLC
520 Broad St.
Newark,  NJ  07102
Applicant Contact Gavriel Feuer
Correspondent
Nilo Medical Consulting Group, LLC
3706 Butler St.
Suite #313
Pittsburgh,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
EMF  
Date Received08/15/2024
Decision Date 12/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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