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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 K990463
Device Name MEDLINE EXCEL WHEELCHAIRS
Applicant
Medline
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact LARA N SIMMONS
Correspondent
Medline
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact LARA N SIMMONS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/12/1999
Decision Date 03/15/1999
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
Predetermined Change
Control Plan Authorized		 No
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