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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 K041054
Device Name MEDLINE STRIDER MAXI 3
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact ANDREA HAFERKAMP
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact ANDREA HAFERKAMP
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/23/2004
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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