FDA 510(k) Application Details - K082701

Device Classification Name	Device, Cystometric, Hydraulic   More FDA Info for this Device
510(K) Number	K082701
Device Name	Device, Cystometric, Hydraulic
Applicant	URODYNAMIX TECHNOLOGIES LTD 1485-555 BURRARD STREET BOX 213 VANCOUVER BC V7X 1M9 CA Other 510(k) Applications for this Company
Contact	ANDRE KINDSVATER 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	09/16/2008
Decision Date	12/18/2008
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