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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name agents, embolic, for treatment of uterine fibroids
510(k) Number K133447
Device Name EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
Applicant
CELONOVA BIOSCIENCES, INC.
18615 TUSCANY STONE
SUITE 100
SAN ANTONIO,  TX  78258
Applicant Contact NICOLE BARBER
Correspondent
CELONOVA BIOSCIENCES, INC.
18615 TUSCANY STONE
SUITE 100
SAN ANTONIO,  TX  78258
Correspondent Contact NICOLE BARBER
Regulation Number870.3300
Classification Product Code
NAJ  
Subsequent Product Code
KRD  
Date Received11/12/2013
Decision Date 02/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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