Clearance Summary
DECANTER MODELS-VARIOUS received FDA 510(k) clearance under submission number K830232, sponsored by Steri-Sytems, Corp.. 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 1983-02-09.
- Submission: K830232
- Applicant / Sponsor: Steri-Sytems, Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 1983-02-09
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.