The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Interventiouns Electrosurgical Probes.
| Device ID | K965007 |
| 510k Number | K965007 |
| Device Name: | ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Mountain View, CA 94025 |
| Contact | Michael Kwan, Ph.d. |
| Correspondent | Michael Kwan, Ph.d. 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 | 1996-12-16 |
| Decision Date | 1997-02-06 |