Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K220996 |
Device Name |
Duoblade |
Applicant |
CnC Technologies |
E1101, Gwang Myeong Technopark, 60, Haan-Ro |
Gwangmyeong-Si,
KR
14322
|
|
Applicant Contact |
InSang Choi |
Correspondent |
KMC, Inc. |
Room no. 1709, 123, Digital-ro 26-gil, Guro-gu |
Seoul,
KR
08390
|
|
Correspondent Contact |
WooSeok Jeong |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/04/2022 |
Decision Date | 02/03/2023 |
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
|
|
|