FDA 510(k) Application Details - DEN160040

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160040
Device Name	Embosphere Microspheres
Applicant	Biosphere Medical S.A. a wholly owned subsidiary of Merit Medical Systems Inc. Parc des Nations-Paris Nord 2 383 Rue de la Belle Etoile 95700 FR Other 510(k) Applications for this Company
Contact	Alix Fonlladosa Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2016
Decision Date	06/21/2017
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review