Clearance Summary
COMBI-CAP received FDA 510(k) clearance under submission number K892428, 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 1989-07-14.
- Submission: K892428
- Applicant / Sponsor: The Medi-Dose Group
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1989-07-14
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.