Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K192545 |
Device Name |
Potenza |
Applicant |
Jeisys Medical Incorporated |
307 Daeyung Techno Town 8th; Gamasan-ro 96, Geumcheon-Gu |
Seoul,
KR
08501
|
|
Applicant Contact |
Wonchel Choi |
Correspondent |
IQVIA |
18 Bridie Lane |
Norfolk,
MA
02056
|
|
Correspondent Contact |
Pamela J Weagraff |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/16/2019 |
Decision Date | 02/20/2020 |
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
|