Clearance Summary
CENTURION PROTECTIVE RESTRAINT, SCR SERIES received FDA 510(k) clearance under submission number K080448, 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 2008-08-28.
- Submission: K080448
- Applicant / Sponsor: Tri-State Hospital Supply Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6760
- Decision date: 2008-08-28
Classification & Regulation
This clearance is catalogued under FDA product code FMQ and 21 CFR 880.6760, within the General Hospital review panel as a Class I device.