Clearance Summary
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 received FDA 510(k) clearance under submission number K041280, sponsored by Felton International, 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 2004-06-24.
- Submission: K041280
- Applicant / Sponsor: Felton International, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5430
- Decision date: 2004-06-24
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.