The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Rf Generator And Accessories, Model 500 Series.
| Device ID | K983214 |
| 510k Number | K983214 |
| Device Name: | RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
| Contact | Dan Balbierz |
| Correspondent | Dan Balbierz RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 2000-03-27 |
| Summary: | summary |