The following data is part of a premarket notification filed by Rita Medical Systems Inc with the FDA for Rita Model 1500x Electrosurgical Rf Generator And Accessories (e.g., Rita Thermo Pad And Cable Adapter).
| Device ID | K031926 |
| 510k Number | K031926 |
| Device Name: | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RITA MEDICAL SYSTEMS INC 967 N. SHORELINE BLVD. Mountain View, CA 94043 |
| Contact | Erin Mazzone |
| Correspondent | Erin Mazzone RITA MEDICAL SYSTEMS INC 967 N. SHORELINE BLVD. Mountain View, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2003-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H7877001032850 | K031926 | 000 |
| H7877001026490 | K031926 | 000 |