MEDLINE VIAL DECANTER

Set, I.v. Fluid Transfer

MEDLINE INDUSTRIES, INC.

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

Pre-market Notification Details

Device IDK111577
510k NumberK111577
Device Name:MEDLINE VIAL DECANTER
ClassificationSet, I.v. Fluid Transfer
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-07
Decision Date2011-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889942692682 K111577 000
40889942499282 K111577 000

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