The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Ora-50 Electrothermal System And Accessories.
| Device ID | K994333 |
| 510k Number | K994333 |
| Device Name: | ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Contact | Sheila Ramerman |
| Correspondent | Sheila Ramerman ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-01-18 |
| Summary: | summary |