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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K991954
Device Name THE BRUNO POWERBASE, MODEL PSB-2200
Applicant
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
Oconomowoc,  WI  53066
Applicant Contact WILLIAM W BELSON III
Correspondent
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
Oconomowoc,  WI  53066
Correspondent Contact WILLIAM W BELSON III
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/10/1999
Decision Date 11/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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