Clearance Summary
CHEMO-SPIKE RECONSTITUTION DEVICE received FDA 510(k) clearance under submission number K895290, sponsored by The Medi-Dose Group. 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 1989-12-27.
- Submission: K895290
- Applicant / Sponsor: The Medi-Dose Group
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1989-12-27
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.