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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 K231615
Device Name Disposable Endoscopic Bipolar
Applicant
Jiangsu Hope Biomedical Science & Technology Co., Ltd.
#3 Bldg.. High-Tech Innovation Service Center
Jiangdu District
Yangzhou,  CN 225211
Applicant Contact Shaote Geng
Correspondent
Shanghai Jiushun Enterprise Management Technology Service Co
15 Floor, 25 Floor,Bao An Tower,#800
Dongfang Rd.
Shanghai,  CN 200122
Correspondent Contact Kitty Zhang
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/02/2023
Decision Date 12/05/2023
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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