Clearance Summary
F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK received FDA 510(k) clearance under submission number K042129, sponsored by Cedic S.R.L.. 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 2005-01-27.
- Submission: K042129
- Applicant / Sponsor: Cedic S.R.L.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2005-01-27
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.