510(k) K080376
K080376 is an FDA 510(k) premarket notification submitted by Oncobionic Incorporated for the device "ONCOBIONIC SYSTEM". The FDA issued a decision of Substantially Equivalent on April 2, 2008. The device falls under product code OAB (Low Energy Direct Current Thermal Ablation System), a Class II device regulated under 21 CFR 878.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2008
- Date Received
- February 12, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Energy Direct Current Thermal Ablation System
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Ablation of soft tissue