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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 K191942
Device Name MT One Diamond
Applicant
M&T Srl
Via Pietrarubbia, 32/F
Rimini,  IT 4700
Applicant Contact Firorenzo Rossi
Correspondent
Endo Engineering Srl
Via Del Consorzio, 41
Falconara Marittaima,  IT 60015
Correspondent Contact Simonetta Strologo
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONE   ONF   ONG  
Date Received07/22/2019
Decision Date 10/17/2019
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
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