Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K221277 |
Device Name |
Mygen M-3004 RF Generator M-3004 |
Applicant |
RF Medical Co., Ltd |
#502, 503, 506, 511, 254, Beotkkot-ro, Geumcheon-gu, |
Seoul,
KR
08511
|
|
Applicant Contact |
Kwang S Choi |
Correspondent |
Mtech Group |
7505 Fannin St, Suite 610 |
Houston,
TX
77054
|
|
Correspondent Contact |
Dave Kim |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/03/2022 |
Decision Date | 09/02/2022 |
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
|
|
|