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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 K894112
Device Name RAOMER
Applicant
Niagara Corp.
1100 Hwy. 27 S.
P.O. Box 1100
Stanley,  NC  28164
Applicant Contact PAUL GRAVES
Correspondent
Niagara Corp.
1100 Hwy. 27 S.
P.O. Box 1100
Stanley,  NC  28164
Correspondent Contact PAUL GRAVES
Regulation Number890.3800
Classification Product Code
INI  
Date Received06/12/1989
Decision Date 07/25/1989
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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