Clearance Summary
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM received FDA 510(k) clearance under submission number K014013, sponsored by H & W Technology, LLC. 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 2003-06-25.
- Submission: K014013
- Applicant / Sponsor: H & W Technology, LLC
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6860
- Decision date: 2003-06-25
Classification & Regulation
This clearance is catalogued under FDA product code FLF and 21 CFR 880.6860, within the General Hospital review panel as a Class II device.