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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K240604
Device Name MTONE EVO (MTONE EVO)
Applicant
M&T S.R.L.
Via Pietrarubbia 32/F
Rimini,  IT 47900
Applicant Contact Fiorenzo Rossi
Correspondent
M&T S.R.L.
Via Pietrarubbia 32/F
Rimini,  IT 47900
Correspondent Contact Fiorenzo Rossi
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONE   ONF   ONG  
Date Received03/04/2024
Decision Date 09/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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