Clearance Summary
BILI BLUE F20T12/BBY AND F40T12/BBY received FDA 510(k) clearance under submission number K090192, sponsored by Interlectric Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-04-24.
- Submission: K090192
- Applicant / Sponsor: Interlectric Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 2009-04-24
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.