Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K233615 |
Device Name |
Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS- |
Applicant |
Baisheng Medical Co., Ltd. |
No.11, Fusheng Road, Xinhui District |
Jiangmen,
CN
529100
|
|
Applicant Contact |
Xi Chen |
Correspondent |
Baisheng Medical Co., Ltd. |
No.11, Fusheng Road, Xinhui District |
Jiangmen,
CN
529100
|
|
Correspondent Contact |
Sylvia Dong |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/13/2023 |
Decision Date | 01/08/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|