Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K200875 |
Device Name |
ArtiSential Laparoscopic Instruments - Electrodes |
Applicant |
LivsMed Inc. |
#304, D-dong, 700, Pangyo-ro, Bundang-gu |
Seongnam-si,
KR
13516
|
|
Applicant Contact |
Dong Wook Lee |
Correspondent |
LivsMed Inc. |
#304, D-dong, 700, Pangyo-ro, Bundang-gu |
Seongnam-si,
KR
13516
|
|
Correspondent Contact |
Dong Wook Lee |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/01/2020 |
Decision Date | 06/17/2020 |
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
|
|
|