Clearance Summary
HAND-CARRIED STRETCHERS/BREAK AWAY FLAT received FDA 510(k) clearance under submission number K904511, sponsored by Minto Research & Development, 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 1990-10-12.
- Submission: K904511
- Applicant / Sponsor: Minto Research & Development, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6900
- Decision date: 1990-10-12
Classification & Regulation
This clearance is catalogued under FDA product code FPP and 21 CFR 880.6900, within the General Hospital review panel as a Class I device.