FDA 510(k) Application Details - K073552

Device Classification Name	Device, Cystometric, Hydraulic   More FDA Info for this Device
510(K) Number	K073552
Device Name	Device, Cystometric, Hydraulic
Applicant	LABORIE MEDICAL TECHNOLOGIES, CORP 400 AVE D, STE 10 WILLISTON, VT 05495 US Other 510(k) Applications for this Company
Contact	BARBARA MORNET Other 510(k) Applications for this Contact
Regulation Number	876.1620   More FDA Info for this Regulation Number
Classification Product Code	FEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2007
Decision Date	03/05/2008
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