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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K221410
Device Name Maestro Platform
Applicant
Moon Surgical
C/O Sofinnova Partners, 7/11 Bd Haussmann
Paris,  FR 75009
Applicant Contact Anne Osdoit
Correspondent
Daniel & Daniel Consulting
340 Jones Lane
Gerdnerville,  NV  89460
Correspondent Contact Michael Daniel
Regulation Number878.4960
Classification Product Code
FQO  
Date Received05/16/2022
Decision Date 12/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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