RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder

Needle, Hypodermic, Single Lumen

MYCO Medical Supplies, Inc.

The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Reli Safety Blood Collection Tube Holder, Reli Blood Collection Tube Holder.

Pre-market Notification Details

Device IDK173279
510k NumberK173279
Device Name:RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
ClassificationNeedle, Hypodermic, Single Lumen
Applicant MYCO Medical Supplies, Inc. 2015 Production Drive Apex,  NC  27539
ContactSanjiv Kumar
CorrespondentE. J. Smith
Smith Associates 1468 Harwell Ave. Crofton,  MD  21114
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-13
Decision Date2018-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20386120009203 K173279 000
20386120007414 K173279 000
20386120011275 K173279 000

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