Clearance Summary
ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 received FDA 510(k) clearance under submission number K033099, sponsored by Applied Diabetes Research, Incorporated. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-10-16.
- Submission: K033099
- Applicant / Sponsor: Applied Diabetes Research, Incorporated
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2003-10-16
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.