Clearance Summary
SPAN / AID SYRINGE received FDA 510(k) clearance under submission number K854255, sponsored by Span-America Medical Systems, 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 1985-11-12.
- Submission: K854255
- Applicant / Sponsor: Span-America Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1985-11-12
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.