DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921— 510(k) K052743

Clearance details

Applicant

Dynarex Corp.

Product code

Code CBP

Device class

Class 2

Regulation

21 CFR 868.5870

Advisory panel

Anesthesiology

Date received

2005-09-30

Decision date

2005-12-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Orangeburg, NY, US

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• Z-2117-2014 — CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.Class II·Terminated·Dynarex Corporation·20140702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052743.