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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 K970646
Device Name SAFARI
Applicant
Ranger All Season Corp.
P.O. Box 132
George,  IA  51237
Applicant Contact RON STEWART
Correspondent
Ranger All Season Corp.
P.O. Box 132
George,  IA  51237
Correspondent Contact RON STEWART
Regulation Number890.3800
Classification Product Code
INI  
Date Received02/11/1997
Decision Date 08/25/1997
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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