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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
Model 50C-0105-1
Device Name MOUNTED MEDICAL OXYGEN SYSTEM
Original Applicant
ESSEX INDUSTRIES, INC.
8007 chivvis drive
st. louis,  MO  63123
Original Contact ken seise
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received12/21/2011
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
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