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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 K193266
Device Name MIIN
Applicant
Medico USA, Inc.
3407 W 6th St. Suite 507
Los Angeles,  CA  90020
Applicant Contact Peter Son
Correspondent
Provision Consulting Group, Inc.
100 Barranca St. Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Kwon
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/26/2019
Decision Date 01/22/2021
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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