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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 K211228
Device Name Rosso
Applicant
Quanta System SpA
Via Acquedotto 109
Samarate,  IT Varese
Applicant Contact Francesco Dell'Antonio
Correspondent
Quanta System SpA
Via Acquedotto 109
Samarate,  IT Varese
Correspondent Contact Dario Bandiera
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/23/2021
Decision Date 02/02/2022
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
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