Clearance Summary
SAF-LIFT/SAF-KARY received FDA 510(k) clearance under submission number K926411, sponsored by Arjo-Century, 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 1993-03-31.
- Submission: K926411
- Applicant / Sponsor: Arjo-Century, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5500
- Decision date: 1993-03-31
Classification & Regulation
This clearance is catalogued under FDA product code FNG and 21 CFR 880.5500, within the General Hospital review panel as a Class II device.