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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transport, patient, powered
510(k) Number K113308
Model SRE-3000
Device Name BRUNO ELAN STAIRWAY ELEVATOR
Original Applicant
BRUNO INDEPENDENT LIVING AIDS, INC.
1780 executive dr.
oconomowoc,  WI  53066
Original Contact terrence o'brien
Regulation Number890.5150
Classification Product Code
ILK  
Date Received11/09/2011
Decision Date 02/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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