Cleared Traditional

POWER-LOAD COT FASTENER SYSTEM

K113598 · Stryker Medical · General Hospital
Dec 2011
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K113598 is an FDA 510(k) clearance for the POWER-LOAD COT FASTENER SYSTEM, a Stretcher, Wheeled (Class II — Special Controls, product code FPO), submitted by Stryker Medical (Portage, US). The FDA issued a Cleared decision on December 20, 2011, 15 days after receiving the submission on December 5, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K113598 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2011
Decision Date December 20, 2011
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPO — Stretcher, Wheeled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6910

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