Clearance Summary
PARAGON INFUSION received FDA 510(k) clearance under submission number K984146, sponsored by I-Flow Corp.. 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 1999-02-09.
- Submission: K984146
- Applicant / Sponsor: I-Flow Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1999-02-09
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.