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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cylinder, Compressed Gas, And Valve
510(k) Number K131386
Device Name EZ-OX PLUS GENERATION II
Applicant
Air Liquide Healthcare America
2700 Post Oak Blvd. Suite 1800
Houston,  TX  77056
Applicant Contact ANGIE BEYER
Correspondent
Air Liquide Healthcare America
2700 Post Oak Blvd. Suite 1800
Houston,  TX  77056
Correspondent Contact ANGIE BEYER
Regulation Number868.2700
Classification Product Code
ECX  
Date Received05/14/2013
Decision Date 03/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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