FDA 510(k) Application Details - K132675

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K132675
Device Name	Device, Vascular, For Promoting Embolization
Applicant	CELONOVA BIOSCIENCES, INC. 18615 Tuscany Stone Ste 100 San Antonio, TX 78258 US Other 510(k) Applications for this Company
Contact	NICOLE BARBER Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2013
Decision Date	10/03/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review