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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K141209
Device Name EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE 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
KRD  
Subsequent Product Code
NAJ  
Date Received05/09/2014
Decision Date 08/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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