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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
510(k) Number K112769
Device Name CURAD COMPRESSION HOSIERY
Applicant
MEDLINE, INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact MATT CLAUSEN
Correspondent
MEDLINE, INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact MATT CLAUSEN
Regulation Number880.5780
Classification Product Code
DWL  
Date Received09/23/2011
Decision Date 03/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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