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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 K925122
Device Name PACE SAVER LITTLE JR
Applicant
Burke Mobility Products
P.O. Box 1064
Mission,  KS  66222
Applicant Contact DUWAYNE E KRAMER
Correspondent
Burke Mobility Products
P.O. Box 1064
Mission,  KS  66222
Correspondent Contact DUWAYNE E KRAMER
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/09/1992
Decision Date 03/30/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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