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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 K881766
Device Name REM 250 THREE WHEELED ELECTRIC CART
Applicant
Royal Enterprises Manufacturing, Inc.
3005 Perry St.
Madison,  WI  53713
Applicant Contact PAUL R GRAVES
Correspondent
Royal Enterprises Manufacturing, Inc.
3005 Perry St.
Madison,  WI  53713
Correspondent Contact PAUL R GRAVES
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/25/1988
Decision Date 05/17/1988
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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