Clearance Summary
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC received FDA 510(k) clearance under submission number K864780, sponsored by Mac Lee Medical 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 1986-12-23.
- Submission: K864780
- Applicant / Sponsor: Mac Lee Medical Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1986-12-23
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.