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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K131990
Device Name OXYGEN GENERATOR LIQUEFIER - (OGL)
Applicant
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 CHIVVIS DR.
ST. LOUIS,  MO  63123
Applicant Contact PAUL DRYDEN
Correspondent
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 CHIVVIS DR.
ST. LOUIS,  MO  63123
Correspondent Contact PAUL DRYDEN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/28/2013
Decision Date 02/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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