Clearance Summary
CONFIDOSE IM AUTO-INJECTOR received FDA 510(k) clearance under submission number K060389, sponsored by Pharma-Pen, Inc.. 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 2006-06-06.
- Submission: K060389
- Applicant / Sponsor: Pharma-Pen, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6920
- Decision date: 2006-06-06
Classification & Regulation
This clearance is catalogued under FDA product code KZH and 21 CFR 880.6920, within the General Hospital review panel as a Class II device.