Cultura Collection And Transport System

Culture Media, Non-propagating Transport

Merit Medical Systems, Inc

The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Cultura Collection And Transport System.

Pre-market Notification Details

Device IDK201674
510k NumberK201674
Device Name:Cultura Collection And Transport System
ClassificationCulture Media, Non-propagating Transport
Applicant Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan,  UT  84095
ContactAlex Bohorquez
CorrespondentAlex Bohorquez
Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-19
Decision Date2021-03-03

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