Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K222709 |
Device Name |
Retraction, CWM-910T, APOLEX Tite |
Applicant |
Chungwoo CO., LTD. |
(Gasan-dong, Woolim Lionsvally-2), 614, 2, |
Gasandigital 1-ro, Geumcheon-gu |
Seoul,
KR
08591
|
|
Applicant Contact |
Il Kwon Lee |
Correspondent |
KMC, Inc. |
(G-Plus Tower, # 1709) 123, Digital-ro 26-gil, Guro-gu |
Seoul,
KR
08390
|
|
Correspondent Contact |
Milly , |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/08/2022 |
Decision Date | 03/21/2023 |
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
|
|
|