Clearance Summary
INFUSION NEEDLE SET received FDA 510(k) clearance under submission number K791529, sponsored by I.M.P. Group , 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 1979-10-02.
- Submission: K791529
- Applicant / Sponsor: I.M.P. Group , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1979-10-02
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.