The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Systems.
| Device ID | K040989 |
| 510k Number | K040989 |
| Device Name: | RITA SYSTEMS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
| Contact | Darrin Uecker |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-16 |
| Decision Date | 2004-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H7877001026480 | K040989 | 000 |
| H7877001029410 | K040989 | 000 |
| H787700101731M0 | K040989 | 000 |
| H7877001018920 | K040989 | 000 |
| H7877001023311 | K040989 | 000 |
| H7877001023300 | K040989 | 000 |