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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K111147
Device Name MEDLINE VESSEL CANNULA
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 Number870.4210
Classification Product Code
DWF  
Date Received04/25/2011
Decision Date 07/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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