Fiber Dust
Powered Laser Surgical Instrument
Quanta System Spa
The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Fiber Dust.
Pre-market Notification Details
| Device ID | K210142 |
| 510k Number | K210142 |
| Device Name: | Fiber Dust |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System Spa via Acquedotto 109 Samarate (va), IT 21017 |
| Contact | Francesco Dell'antonio |
| Correspondent | Francesco Dell'antonio Quanta System Spa via Acquedotto 109 Samarate (va), IT 21017 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-03-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08059173391783 | K210142 | 000 |
Trademark Results [Fiber Dust]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBER DUST 79323706 not registered Live/Pending |
QUANTA SYSTEM S.P.A. 2021-09-16 |
 FIBER DUST 79322833 not registered Live/Pending |
QUANTA SYSTEM S.P.A. 2021-09-16 |
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