Clearance Summary
H.U. I.V. DROP COUNTER received FDA 510(k) clearance under submission number K893693, sponsored by Li-Lien 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 1989-10-27.
- Submission: K893693
- Applicant / Sponsor: Li-Lien Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2420
- Decision date: 1989-10-27
Classification & Regulation
This clearance is catalogued under FDA product code FLN and 21 CFR 880.2420, within the General Hospital review panel as a Class II device.