The following data is part of a premarket notification filed by Oncobionics, Inc. with the FDA for Oncobionic System.
| Device ID | K060054 |
| 510k Number | K060054 |
| Device Name: | ONCOBIONIC SYSTEM |
| Classification | Low Energy Direct Current Thermal Ablation System |
| Applicant | ONCOBIONICS, INC. 1700 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Laurie A Clarke |
| Correspondent | Laurie A Clarke ONCOBIONICS, INC. 1700 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | OAB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-06 |
| Decision Date | 2006-11-21 |
| Summary: | summary |