The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Starburst Sde Electrosurgical Device.
| Device ID | K030967 |
| 510k Number | K030967 |
| Device Name: | RITA STARBURST SDE ELECTROSURGICAL DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
| Contact | Erin Mazzone |
| Correspondent | Erin Mazzone RITA MEDICAL SYSTEMS 967 NORTH 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 | 2003-03-26 |
| Decision Date | 2003-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H7877001039081 | K030967 | 000 |
| H7877001024861 | K030967 | 000 |