FDA 510(k) Application Details - K032257

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K032257
Device Name	Pump, Infusion, Insulin
Applicant	ANIMAS CORP. 590 E. LANCASTER AVE. FRAZER, PA 19355 US Other 510(k) Applications for this Company
Contact	MICHAEL J ANDREWS Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	LZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2003
Decision Date	10/16/2003
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