The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Interventions Model Ora 50 Electrothermal Generator.
| Device ID | K964071 |
| 510k Number | K964071 |
| Device Name: | ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Mountain View, CA 94025 |
| Contact | Hugh Sharkey |
| Correspondent | Hugh Sharkey ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Mountain View, CA 94025 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-11 |
| Decision Date | 1996-12-12 |