Clearance Summary
STERILEMAX received FDA 510(k) clearance under submission number K953938, sponsored by Barnstead/Thermolyne 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 1997-01-30.
- Submission: K953938
- Applicant / Sponsor: Barnstead/Thermolyne Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 1997-01-30
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.