FDA 510(k) Application Details - K003443

Device Classification Name	System, Evacuator, Fluid   More FDA Info for this Device
510(K) Number	K003443
Device Name	System, Evacuator, Fluid
Applicant	APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 US Other 510(k) Applications for this Company
Contact	ANIL BHALANI Other 510(k) Applications for this Contact
Regulation Number	876.4370   More FDA Info for this Regulation Number
Classification Product Code	FHF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2000
Decision Date	02/01/2001
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