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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 K202601
Device Name Single-use Sterile medical laser fiber
Applicant
Realton (Suzhou) Medical Technology Co., Ltd.
601 Rm., B8 Bldg., 218 Xinghu Rd.,
Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact Mingzhu Liu
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., Panyu
District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/08/2020
Decision Date 12/15/2020
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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