The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Ultrawave Iii Ex 1320.
| Device ID | K083207 |
| 510k Number | K083207 |
| Device Name: | ULTRAWAVE III EX 1320 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona(va), IT 21058 |
| Contact | Isabella Carrer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-31 |
| Decision Date | 2008-11-14 |
| Summary: | summary |