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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 K153518
Device Name Medipure Oxygen-LC System
Applicant
Praxair Distribution, Incorporated.
175 E Park Dr.
Tonawanda,  NY  14150
Applicant Contact Michael Skrjanc
Correspondent
Emergo Global Consulting, LLC
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Audrey Swearingen
Regulation Number868.2700
Classification Product Code
ECX  
Date Received12/08/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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