Clearance Summary
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 received FDA 510(k) clearance under submission number K100947, sponsored by Calibra Medical, Inc.. 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 2010-06-28.
- Submission: K100947
- Applicant / Sponsor: Calibra Medical, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2010-06-28
Classification & Regulation
This clearance is catalogued under FDA product code OPP and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.