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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 K873609
Device Name VEHICLE, MOTORIZED (3-WHEELED ELECTRIC CART)
Applicant
American Dynatec Corp.
5311 Fuller St.
Schofield,  WI  54476
Applicant Contact MICHAEL J KOSS
Correspondent
American Dynatec Corp.
5311 Fuller St.
Schofield,  WI  54476
Correspondent Contact MICHAEL J KOSS
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/08/1987
Decision Date 10/19/1987
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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