The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Interventions Model Orastat Monopolar Cautery Device.
| Device ID | K973158 |
| 510k Number | K973158 |
| Device Name: | ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Contact | Michael Kwan |
| Correspondent | Michael Kwan ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, 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 | 1997-08-22 |
| Decision Date | 1997-11-05 |