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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 K964954
Device Name SUPERLIGHT
Applicant
Wheelcare Scooters, Inc.
3883 - E Via Prescador
Camarillo,  CA  93012
Applicant Contact HAROLD GUTTERMAN
Correspondent
Wheelcare Scooters, Inc.
3883 - E Via Prescador
Camarillo,  CA  93012
Correspondent Contact HAROLD GUTTERMAN
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/11/1996
Decision Date 03/20/1997
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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