The following data is part of a premarket notification filed by Oncobionics, Inc. with the FDA for Oncobionic System With 6 Probe Output.
| Device ID | K080202 |
| 510k Number | K080202 |
| Device Name: | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT |
| Classification | Low Energy Direct Current Thermal Ablation System |
| Applicant | ONCOBIONICS, INC. 30211 AVENIDA DE LAS BANDERAS SUITE 200 Rancho Santa Margarita, CA 92679 |
| Contact | Paul Mikus |
| Correspondent | Paul Mikus ONCOBIONICS, INC. 30211 AVENIDA DE LAS BANDERAS SUITE 200 Rancho Santa Margarita, CA 92679 |
| Product Code | OAB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-28 |
| Decision Date | 2008-05-08 |
| Summary: | summary |