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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, double lumen for intestinal decompression and/or intubation
510(k) Number K132314
Device Name MEDLINE ANTI-REFLUX VALVE
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 Number876.5980
Classification Product Code
FEG  
Date Received07/25/2013
Decision Date 09/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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