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510(k) K231615

Device
Disposable Endoscopic Bipolar
Applicant
Jiangsu Hope Biomedical Science & Technology Co., Ltd.
510(k) number
K231615
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-05
Date received
2023-06-02
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shaote Geng
Address
#3 Bldg.. High-Tech Innovation Service Center Jiangdu District Yangzhou CN 225211 225211

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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