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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, liquid-oxygen, portable
510(k) Number K113767
Device Name MOUNTED MEDICAL OXYGEN SYSTEM
Applicant
ESSEX INDUSTRIES, INC.
8007 CHIVVIS DRIVE
ST. LOUIS,  MO  63123
Applicant Contact KEN SEISE
Correspondent
ESSEX INDUSTRIES, INC.
8007 CHIVVIS DRIVE
ST. LOUIS,  MO  63123
Correspondent Contact KEN SEISE
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received12/21/2011
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
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