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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 K915609
Device Name ULTRA R-11 CRUISER
Applicant
Brookefield Hunter, Inc.
880 N. Main St.
Oregon,  WI  53575
Applicant Contact RON ERFURTH
Correspondent
Brookefield Hunter, Inc.
880 N. Main St.
Oregon,  WI  53575
Correspondent Contact RON ERFURTH
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/05/1991
Decision Date 02/11/1992
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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