The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Model 1500 Electrosurgical Generator, Power Cord,footswitch,main Cable, Dispersive Electrode.
| Device ID | K993944 |
| 510k Number | K993944 |
| Device Name: | RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
| Contact | Erin Dignan-mazzone |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-11-19 |
| Decision Date | 1999-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H7877001026230 | K993944 | 000 |