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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 K033829
Device Name BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100
Applicant
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
P.O. Box 84
Oconomowoc,  WI  53066
Applicant Contact RICHARD KELLER
Correspondent
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
P.O. Box 84
Oconomowoc,  WI  53066
Correspondent Contact RICHARD KELLER
Regulation Number890.5150
Classification Product Code
ILK  
Date Received12/09/2003
Decision Date 12/29/2003
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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