Clearance Summary
CLICK-COUNT U100 INSULIN SYRINGE received FDA 510(k) clearance under submission number K833706, sponsored by Orange Medical Instruments, 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 1984-04-05.
- Submission: K833706
- Applicant / Sponsor: Orange Medical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1984-04-05
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.