Guarded Luer Connector

Set, I.v. Fluid Transfer

International Medical Industries Inc.

The following data is part of a premarket notification filed by International Medical Industries Inc. with the FDA for Guarded Luer Connector.

Pre-market Notification Details

Device IDK173577
510k NumberK173577
Device Name:Guarded Luer Connector
ClassificationSet, I.v. Fluid Transfer
Applicant International Medical Industries Inc. 2981 Gateway Drive Pompano Beach,  FL  33069
ContactBrandon Hunt
CorrespondentKathleen Lavender
International Medical Industries Inc. 2981 Gateway Drive Pompano Beach,  FL  33069
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-20
Decision Date2018-06-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B212574012 K173577 000
B212574002 K173577 000
B212574032 K173577 000
B212574022 K173577 000
B21257400W1 K173577 000

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