Clearance Summary
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI received FDA 510(k) clearance under submission number K111517, sponsored by Pharmajet, 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 2011-07-27.
- Submission: K111517
- Applicant / Sponsor: Pharmajet, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5430
- Decision date: 2011-07-27
Classification & Regulation
This clearance is catalogued under FDA product code KZE and 21 CFR 880.5430, within the General Hospital review panel as a Class II device.