BEARING NSPVA EMBOLIZATION PARTICLES

Agents, Embolic, For Treatment Of Uterine Fibroids

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Bearing Nspva Embolization Particles.

Pre-market Notification Details

Device IDK130259
510k NumberK130259
Device Name:BEARING NSPVA EMBOLIZATION PARTICLES
ClassificationAgents, Embolic, For Treatment Of Uterine Fibroids
Applicant MERIT MEDICAL SYSTEMS, INC. 1050 HINGHAM ST Rockland,  MA  02370
ContactLinda Varroso
CorrespondentLinda Varroso
MERIT MEDICAL SYSTEMS, INC. 1050 HINGHAM ST Rockland,  MA  02370
Product CodeNAJ  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-01
Decision Date2013-06-07
Summary:summary

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