FDA 510(k) Application Details - K991543

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K991543
Device Name	Pump, Infusion, Elastomeric
Applicant	I-FLOW CORP. 20202 WINDROW DR. LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	STANLEY E FRY Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/1999
Decision Date	10/25/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review