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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K132767
Device Name MEDLINE SHARPS CONTAINER
Applicant
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Applicant Contact TIMUR SELIMKHANOV
Correspondent
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Correspondent Contact TIMUR SELIMKHANOV
Regulation Number880.5570
Classification Product Code
MMK  
Date Received09/04/2013
Decision Date 02/03/2014
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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