Clearance Summary
SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE received FDA 510(k) clearance under submission number K952518, sponsored by Medi-Dose, 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 1995-07-28.
- Submission: K952518
- Applicant / Sponsor: Medi-Dose, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1995-07-28
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.