Clearance Summary
HT-WEDGE received FDA 510(k) clearance under submission number K121287, sponsored by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L. 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 2012-10-03.
- Submission: K121287
- Applicant / Sponsor: D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5500
- Decision date: 2012-10-03
Classification & Regulation
This clearance is catalogued under FDA product code FNG and 21 CFR 880.5500, within the General Hospital review panel as a Class II device.