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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software Controlled Endoscope And Instrument Holder
510(k) Number K242323
Device Name Maestro System (REF100)
Applicant
Moon Surgical
9 Rue D'Enghien
Paris,  FR 75010
Applicant Contact Anne Osdoit
Correspondent
Daniel & Daniel Consulting
P.O. Box 129
Minden,  NV  89423
Correspondent Contact Michael Daniel
Regulation Number876.1500
Classification Product Code
QZB  
Date Received08/06/2024
Decision Date 03/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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