Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K202503 |
Device Name |
Chrome |
Applicant |
Quanta System Spa |
via Acquedotto, 109 |
Samarate (Va),
IT
21017
|
|
Applicant Contact |
Francesco Dell'Antonio |
Correspondent |
Quanta System Spa |
via Acquedotto, 109 |
Samarate (Va),
IT
21017
|
|
Correspondent Contact |
Francesco Dell'Antonio |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/31/2020 |
Decision Date | 11/18/2020 |
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
|