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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 K922338
Device Name X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER
Applicant
Am Scooters
P.O. Box 22137
Sarasota,  FL  34276
Applicant Contact NIELSEN
Correspondent
Am Scooters
P.O. Box 22137
Sarasota,  FL  34276
Correspondent Contact NIELSEN
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/19/1992
Decision Date 06/11/1992
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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