Clearance Summary
STRAIGHT-LINES I.V. ORGANIZER received FDA 510(k) clearance under submission number K920965, sponsored by Taylor Bio-Medical, Inc.. 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 1993-04-07.
- Submission: K920965
- Applicant / Sponsor: Taylor Bio-Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6500
- Decision date: 1993-04-07
Classification & Regulation
This clearance is catalogued under FDA product code FRA and 21 CFR 880.6500, within the General Hospital review panel as a Class II device.