Clearance Summary
STERI-AID KIT received FDA 510(k) clearance under submission number K963049, sponsored by Steri-Aid, 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 1996-11-12.
- Submission: K963049
- Applicant / Sponsor: Steri-Aid, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2900
- Decision date: 1996-11-12
Classification & Regulation
This clearance is catalogued under FDA product code FQZ and 21 CFR 880.2900, within the General Hospital review panel as a Class I device.