Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K232703 |
Device Name |
Disposable Bipolar Forceps |
Applicant |
Jiangsu Hope Biomedical Science&Technology Co., Ltd. |
No.3 Building, Hi-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 Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/05/2023 |
Decision Date | 03/06/2024 |
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
|
|
|