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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 K192856
Device Name MT One
Applicant
M&T S.R.L.
Via Pietrarubbia, 32/F
Rimini,  IT 47900
Applicant Contact Fiorenzo Rossi
Correspondent
Endo Engineering
Via Del Consorzio, 41
Falconara Marittima,  IT 60015
Correspondent Contact Chiara Violini
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONE   ONF   ONG  
Date Received10/04/2019
Decision Date 04/24/2020
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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