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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K221743
Device Name Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes
Applicant
Jiangsu Bonss Medical Technology Co., Ltd.
Building #7, No. 898 China Medical City Avenue
Hailing District
Taizhou,  CN 225316
Applicant Contact Feir Zeng
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
9th Floor, R&D Building, No. 26 Qinglan Street
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/15/2022
Decision Date 09/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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