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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
Device Name BRUNO ELAN STAIRWAY ELEVATOR
Applicant
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
Oconomowoc,  WI  53066
Applicant Contact TERRENCE O'BRIEN
Correspondent
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
Oconomowoc,  WI  53066
Correspondent Contact TERRENCE O'BRIEN
Regulation Number890.5150
Classification Product Code
ILK  
Date Received11/09/2011
Decision Date 02/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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