Device Classification Name |
Table, Operating-Room, Ac-Powered
|
510(k) Number |
K221410 |
Device Name |
Maestro Platform |
Applicant |
Moon Surgical |
c/o Sofinnova Partners, 7/11 Bd Haussmann |
Paris,
FR
75009
|
|
Applicant Contact |
Anne Osdoit |
Correspondent |
Daniel & Daniel Consulting |
340 Jones Lane |
Gardnerville,
NV
89460
|
|
Correspondent Contact |
Michael Daniel |
Regulation Number | 878.4960
|
Classification Product Code |
|
Date Received | 05/16/2022 |
Decision Date | 12/02/2022 |
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
|
|
|