FDA 510(k) Application Details - K011317

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K011317
Device Name	Pump, Infusion, Elastomeric
Applicant	BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. ROUND LAKE, IL 60073 US Other 510(k) Applications for this Company
Contact	VICKI L DREWS 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	04/30/2001
Decision Date	06/28/2001
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