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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K921647
Device Name REGAL MOTORIZIED 3 WHEELED VEHICLE
Applicant
Bruno Independent Living Aids, Inc.
430 Armour Ct.
Oconomowoc,  WI  53066
Applicant Contact BELSON III
Correspondent
Bruno Independent Living Aids, Inc.
430 Armour Ct.
Oconomowoc,  WI  53066
Correspondent Contact BELSON III
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/06/1992
Decision Date 05/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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