Clearance Summary
MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM received FDA 510(k) clearance under submission number K973012, sponsored by MDC Research , Ltd.. 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 1997-11-05.
- Submission: K973012
- Applicant / Sponsor: MDC Research , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1997-11-05
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.