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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, mechanical
510(k) Number K051302
Device Name EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact LARA N SIMMONS
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact LARA N SIMMONS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/19/2005
Decision Date 08/15/2005
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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