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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromechanical System For Open Microsurgery
510(k) Number K242368
Device Name Symani Surgical System
Applicant
Medical Microinstruments, Inc.
Via Egidio Giannessi 54
Pisa,  IT 56121
Applicant Contact Zainab Amini
Correspondent
Medical Microinstruments, Inc.
Via Egidio Giannessi 54
Pisa,  IT 56121
Correspondent Contact Zainab Amini
Classification Product Code
SAQ  
Date Received08/09/2024
Decision Date 02/07/2025
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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