Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K200931 |
Device Name |
RF Surgical Generator |
Applicant |
Fulwell LLC |
3411 NW 48 Street |
Miami,
FL
33142
|
|
Applicant Contact |
Perla Melisa Mcliberty |
Correspondent |
Guangzhou KEDA Biological Tech Co., Ltd. |
6F, No.1 TianTai road, Science City, LuoGang District |
Guangzhou,
CN
|
|
Correspondent Contact |
Jet Li |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/07/2020 |
Decision Date | 11/24/2020 |
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
|
|
|