MEDLINE ANTI-REFLUX VALVE

Tube, Double Lumen For Intestinal Decompression And/or Intubation

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Anti-reflux Valve.

Pre-market Notification Details

Device IDK132314
510k NumberK132314
Device Name:MEDLINE ANTI-REFLUX VALVE
ClassificationTube, Double Lumen For Intestinal Decompression And/or Intubation
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeFEG  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-25
Decision Date2013-09-18

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