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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 K051028
Device Name BREEZE
Applicant
Afikim Electric Vehicles
Kibbutz Afikim,  IL 15148
Applicant Contact AVNER FISHBEIN
Correspondent
Afikim Electric Vehicles
Kibbutz Afikim,  IL 15148
Correspondent Contact AVNER FISHBEIN
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/22/2005
Decision Date 01/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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