Cleared Traditional

CENTURION PROTECTIVE RESTRAINT, SCR SERIES

K080448 · Tri-State Hospital Supply Corp. · General Hospital
Aug 2008
Decision
191d
Days
Class 1
Risk

About This 510(k) Submission

K080448 is an FDA 510(k) clearance for the CENTURION PROTECTIVE RESTRAINT, SCR SERIES, a Restraint, Protective (Class I — General Controls, product code FMQ), submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on August 28, 2008, 191 days after receiving the submission on February 19, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.

Submission Details

510(k) Number K080448 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2008
Decision Date August 28, 2008
Days to Decision 191 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMQ — Restraint, Protective
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6760

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