Clearance Summary
STEAM STERILIZATION INDICATOR received FDA 510(k) clearance under submission number K771080, sponsored by Info-Chem. 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 1977-07-14.
- Submission: K771080
- Applicant / Sponsor: Info-Chem
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1977-07-14
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.