MEDLINE GASTROSTOMY TUBE

Tube, Gastro-enterostomy

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Gastrostomy Tube.

Pre-market Notification Details

Device IDK073718
510k NumberK073718
Device Name:MEDLINE GASTROSTOMY TUBE
ClassificationTube, Gastro-enterostomy
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeKGC  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-31
Decision Date2008-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.