Clearance Summary
MICRO 2 HYPODERMIC NEEDLES received FDA 510(k) clearance under submission number K830242, sponsored by Smith & Nephew, Mpl Division. 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 1983-02-15.
- Submission: K830242
- Applicant / Sponsor: Smith & Nephew, Mpl Division
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1983-02-15
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.