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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.
No.3 Building. 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, No.800
Dongfang Road
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
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