Merit 20 ML Syringe

Syringe, Piston

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit 20 Ml Syringe.

Pre-market Notification Details

Device IDK152783
510k NumberK152783
Device Name:Merit 20 ML Syringe
ClassificationSyringe, Piston
Applicant Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan,  UT  84095
ContactCory Marsh
CorrespondentCory Marsh
Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan,  UT  84095
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-25
Decision Date2015-12-07
Summary:summary

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