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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 K102304
Device Name BREEZE C MODEL C (3W), BREEZE C (4W)
Applicant
AFIKIM ELECTRIC VEHICLES
KIBBUTZ AFIKIM
KIBBUTZ AFIKIM,  IL 15148
Applicant Contact AVNER FISHBEIN
Correspondent
AFIKIM ELECTRIC VEHICLES
KIBBUTZ AFIKIM
KIBBUTZ AFIKIM,  IL 15148
Correspondent Contact AVNER FISHBEIN
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/16/2010
Decision Date 01/07/2011
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
Recalls CDRH Recalls
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