Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K221815 |
Device Name |
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) |
Applicant |
Baisheng Medical Co., Ltd. |
No.11, Fusheng Road, Xinhui District, Jiangmen, Guangdong, |
Jiangmen,
CN
529100
|
|
Applicant Contact |
Xi Chen |
Correspondent |
Baisheng Medical Co., Ltd. |
No.11, Fusheng Road, Xinhui District, Jiangmen, Guangdong, |
Jiangmen,
CN
529100
|
|
Correspondent Contact |
Sylvia Dong |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/22/2022 |
Decision Date | 11/23/2022 |
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
|
|
|