Clearance Summary
STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT received FDA 510(k) clearance under submission number K875280, sponsored by Steris C/O Medical Device Consultants, 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 1988-09-13.
- Submission: K875280
- Applicant / Sponsor: Steris C/O Medical Device Consultants, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6885
- Decision date: 1988-09-13
Classification & Regulation
This clearance is catalogued under FDA product code MED and 21 CFR 880.6885, within the General Hospital review panel as a Class II device.