Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K193355 |
Device Name |
Electrodes Handpieces for Mygen V-1000 RF System |
Applicant |
RF Medical Co., Ltd |
#502, 503, 506, 511, 254, Beotkkot-ro, Geumcheon-gu |
Seoul,
KR
|
|
Applicant Contact |
Kwang S Choi |
Correspondent |
MTech Group |
7707 Fannin St. Ste 200 V111 |
Houston,
TX
77054
|
|
Correspondent Contact |
Dave Kim |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/04/2019 |
Decision Date | 08/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|