The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Quanta System Etrna Giovinezza.
| Device ID | K051113 |
| 510k Number | K051113 |
| Device Name: | QUANTA SYSTEM ETRNA GIOVINEZZA |
| Classification | Powered Laser Surgical Instrument |
| Applicant | QUANTA SYSTEM, S.P.A. 10 ELIZABETH DRIVE Chelmsford, MA 01824 |
| Contact | George Cho |
| Correspondent | George Cho QUANTA SYSTEM, S.P.A. 10 ELIZABETH DRIVE Chelmsford, MA 01824 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-02 |
| Decision Date | 2006-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033945934361 | K051113 | 000 |
| 08033945934354 | K051113 | 000 |