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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Specific Transition Connectors
510(k) Number K151628
Device Name Medline ENFit Connectors
Applicant
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Applicant Contact STEPHANIE BLAIR
Correspondent
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Correspondent Contact STEPHANIE BLAIR
Regulation Number876.5980
Classification Product Code
PIO  
Date Received06/17/2015
Decision Date 07/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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