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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 K853766
Device Name ALPHA SUPER KART
Applicant
Alpha Unlimited, Inc.
1610 Northgate Blvd.
Sarasota,  FL  34234
Applicant Contact PENNY LOCKETT
Correspondent
Alpha Unlimited, Inc.
1610 Northgate Blvd.
Sarasota,  FL  34234
Correspondent Contact PENNY LOCKETT
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/09/1985
Decision Date 11/20/1985
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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