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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K935211
Device Name WALK N CHAIR
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 Number890.3850
Classification Product Code
IOR  
Date Received10/29/1993
Decision Date 02/02/1994
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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