Clearance Summary
RAPIDEX BIOLOGICAL SURFACTANT received FDA 510(k) clearance under submission number K862282, sponsored by Rapidex of London. 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 1987-05-11.
- Submission: K862282
- Applicant / Sponsor: Rapidex of London
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6150
- Decision date: 1987-05-11
Classification & Regulation
This clearance is catalogued under FDA product code FLG and 21 CFR 880.6150, within the General Hospital review panel as a Class I device.