Clearance Summary
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 received FDA 510(k) clearance under submission number K014174, 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 2002-02-22.
- Submission: K014174
- Applicant / Sponsor: Barnstead/Thermolyne Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2002-02-22
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.