Clearance Summary
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS received FDA 510(k) clearance under submission number K070430, sponsored by Unomedical A/S. 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 2007-04-04.
- Submission: K070430
- Applicant / Sponsor: Unomedical A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2007-04-04
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.