The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Vulcan Tac Probes, Model 911xxx.
| Device ID | K003198 |
| 510k Number | K003198 |
| Device Name: | VULCAN TAC PROBES, MODEL 911XXX |
| Classification | Arthroscope |
| Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-12 |
| Decision Date | 2001-08-29 |