VACUETTE MULTIPLE SAMPLE LUER ADAPTER

Needle, Hypodermic, Single Lumen

GREINER MEDITECH, INC.

The following data is part of a premarket notification filed by Greiner Meditech, Inc. with the FDA for Vacuette Multiple Sample Luer Adapter.

Pre-market Notification Details

Device IDK981619
510k NumberK981619
Device Name:VACUETTE MULTIPLE SAMPLE LUER ADAPTER
ClassificationNeedle, Hypodermic, Single Lumen
Applicant GREINER MEDITECH, INC. 260 GATEWAY DRIVE, SUITE 17A Bel Air,  MD  21014
ContactDouglas L Harris
CorrespondentDouglas L Harris
GREINER MEDITECH, INC. 260 GATEWAY DRIVE, SUITE 17A Bel Air,  MD  21014
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-06
Decision Date1998-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
39120017570173 K981619 000

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