Clearance Summary
W & H LISA STEAM STERILIZER received FDA 510(k) clearance under submission number K022816, sponsored by A-Dec, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-02-07.
- Submission: K022816
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2003-02-07
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.