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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 K250984
Device Name Maestro System (REF100)
Applicant
Moon Surgical
9 Rue D'Enghien
Paris,  FR 75010
Applicant Contact Anne Osdoit
Correspondent
Moon Surgical
9 Rue D'Enghien
Paris,  FR 75010
Correspondent Contact Marion Bruchet
Regulation Number876.1500
Classification Product Code
QZB  
Date Received03/31/2025
Decision Date 06/27/2025
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		 Yes
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