Clearance Summary
HOME NUTRIBAG MIXING CONTAINER 1000ML received FDA 510(k) clearance under submission number K842628, sponsored by Medical & Pharmaceutical Supplies, 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 1984-09-07.
- Submission: K842628
- Applicant / Sponsor: Medical & Pharmaceutical Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 1984-09-07
Classification & Regulation
This clearance is catalogued under FDA product code KPE and 21 CFR 880.5025, within the General Hospital review panel as a Class II device.