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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 K921467
Device Name DRAKE & DRAKE/200 DL
Applicant
Am Scooters
P.O. Box 22137
Sarasota,  FL  34276
Applicant Contact NIELSEN III
Correspondent
Am Scooters
P.O. Box 22137
Sarasota,  FL  34276
Correspondent Contact NIELSEN III
Regulation Number890.3800
Classification Product Code
INI  
Date Received03/27/1992
Decision Date 04/29/1992
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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