Medline Blood Collection Set

Set, Administration, Intravascular

Medline Industries, Inc.

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

Pre-market Notification Details

Device IDK170002
510k NumberK170002
Device Name:Medline Blood Collection Set
ClassificationSet, Administration, Intravascular
Applicant Medline Industries, Inc. One Medline Place Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
Medline Industries, Inc. One Medline Place Mundelein,  IL  60060
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-03
Decision Date2017-09-19

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