Clearance Summary
CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS received FDA 510(k) clearance under submission number K931748, sponsored by Tri-State Hospital Supply Corp.. 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 1994-02-25.
- Submission: K931748
- Applicant / Sponsor: Tri-State Hospital Supply Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1994-02-25
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.