Clearance Summary
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 received FDA 510(k) clearance under submission number K032976, sponsored by Biovalve Technologies, 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 2004-04-16.
- Submission: K032976
- Applicant / Sponsor: Biovalve Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5430
- Decision date: 2004-04-16
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.