Clearance Summary
POUR BOTTLE DECANTER #2010 received FDA 510(k) clearance under submission number K823538, sponsored by Medi-Plant Intl.. 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 1983-01-26.
- Submission: K823538
- Applicant / Sponsor: Medi-Plant Intl.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 1983-01-26
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.