FDA 510(k) Application Details - K150558

Device Classification Name	More FDA Info for this Device
510(K) Number	K150558
Device Name	Eclipse System
Applicant	Pelvalon, Inc. 923 Thompson Place Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	MILES ROSEN 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	03/04/2015
Decision Date	11/12/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review