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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scale, Platform, Wheelchair
510(k) Number K871391
Device Name AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
Applicant
Amigo Sales, Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Applicant Contact ROBERT K SHRODE
Correspondent
Amigo Sales, Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Correspondent Contact ROBERT K SHRODE
Regulation Number890.3940
Classification Product Code
INF  
Date Received04/07/1987
Decision Date 05/06/1987
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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