EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES

Agents, Embolic, For Treatment Of Uterine Fibroids

CELONOVA BIOSCIENCES, INC.

The following data is part of a premarket notification filed by Celonova Biosciences, Inc. with the FDA for Embozene Color-advanced Microspheres, Embozene Opaque (non-colored) Microspheres.

Pre-market Notification Details

Device IDK133447
510k NumberK133447
Device Name:EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
ClassificationAgents, Embolic, For Treatment Of Uterine Fibroids
Applicant CELONOVA BIOSCIENCES, INC. 18615 TUSCANY STONE SUITE 100 San Antonio,  TX  78258
ContactNicole Barber
CorrespondentNicole Barber
CELONOVA BIOSCIENCES, INC. 18615 TUSCANY STONE SUITE 100 San Antonio,  TX  78258
Product CodeNAJ  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-12
Decision Date2014-02-24
Summary:summary

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