Clearance Summary
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML received FDA 510(k) clearance under submission number K031419, sponsored by Laboratorios Grifols, S.A.. 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 2003-11-24.
- Submission: K031419
- Applicant / Sponsor: Laboratorios Grifols, S.A.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 2003-11-24
Classification & Regulation
This clearance is catalogued under FDA product code KPE and 21 CFR 880.5025, within the General Hospital review panel as a Class II device.