Clearance Summary
SHARPS SAFE 1.5 & SHARPS SAFE 2.0 received FDA 510(k) clearance under submission number K955514, sponsored by Dura-Vac Products. 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 1996-08-01.
- Submission: K955514
- Applicant / Sponsor: Dura-Vac Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1996-08-01
Classification & Regulation
This clearance is catalogued under FDA product code MMK and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.