Clearance Summary
THE FINGER GUARD received FDA 510(k) clearance under submission number K052619, sponsored by T F & G Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-01-06.
- Submission: K052619
- Applicant / Sponsor: T F & G Products
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2006-01-06
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.