FDA 510(k) Application Details - DEN140020

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140020
Device Name	ECLIPSE SYSTEM
Applicant	PELVALON 1171 BARROILHET DRIVE HILLSBOROUGH, CA 94010 US Other 510(k) Applications for this Company
Contact	CINDY DOMECUS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2014
Decision Date	02/12/2015
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	Y