The following data is part of a premarket notification filed by Oncobionic Incorporated with the FDA for Oncobionic System.
| Device ID | K080376 |
| 510k Number | K080376 |
| Device Name: | ONCOBIONIC SYSTEM |
| Classification | Low Energy Direct Current Thermal Ablation System |
| Applicant | ONCOBIONIC INCORPORATED 30211 AVENIDA DE LAS BANDERAS SUITE 200 Rancho Santa Margarita, CA 92688 |
| Contact | Paul Mikus |
| Correspondent | Paul Mikus ONCOBIONIC INCORPORATED 30211 AVENIDA DE LAS BANDERAS SUITE 200 Rancho Santa Margarita, CA 92688 |
| Product Code | OAB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-12 |
| Decision Date | 2008-04-02 |
| Summary: | summary |