FDA 510(k) Application Details - K001386

Device Classification Name	Device, Cystometric, Hydraulic   More FDA Info for this Device
510(K) Number	K001386
Device Name	Device, Cystometric, Hydraulic
Applicant	PELVICARE, INC. 28202 CABOT RD., SUITE 300 LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	WALTER D WALLACH 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	05/02/2000
Decision Date	07/17/2000
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