Clearance Summary
PRECIOUS LITE MODEL 4224 received FDA 510(k) clearance under submission number K854122, sponsored by E & B Technologies, 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 1986-02-07.
- Submission: K854122
- Applicant / Sponsor: E & B Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 1986-02-07
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.