Clearance Summary
ETHYLENE OXIDE STERILI. INDICATOR received FDA 510(k) clearance under submission number K772358, sponsored by Bio-Medical Sciences, 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 1978-01-30.
- Submission: K772358
- Applicant / Sponsor: Bio-Medical Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1978-01-30
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.