FDA 510(k) Application Details - K011598

Device Classification Name	System,Water,Reproduction,Assisted,And Purification   More FDA Info for this Device
510(K) Number	K011598
Device Name	System,Water,Reproduction,Assisted,And Purification
Applicant	IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	WENDELL LEE Other 510(k) Applications for this Contact
Regulation Number	884.6170   More FDA Info for this Regulation Number
Classification Product Code	MTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2001
Decision Date	06/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review