Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K192856 |
Device Name |
MT One |
Applicant |
M&T SRL |
Via Pietrarubbia, 32/F |
Rimini,
IT
47900
|
|
Applicant Contact |
Fiorenzo Rossi |
Correspondent |
Endo Engineering |
Via Del Consorzio, 41 |
Falconara Marittaima,
IT
60015
|
|
Correspondent Contact |
Chiara Violini |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/04/2019 |
Decision Date | 04/24/2020 |
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
|