Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K210693 |
Device Name |
PLEXR PLUS |
Applicant |
GMV S.r.l. |
Via Roberto Parabeni 37 |
Rome,
IT
00173
|
|
Applicant Contact |
Andrea Cancelli |
Correspondent |
GMV S.r.l. |
Via Roberto Parabeni 37 |
Rome,
IT
00173
|
|
Correspondent Contact |
Andrea Cancelli |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/08/2021 |
Decision Date | 03/22/2022 |
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
|