FDA 510(k) Application Details - K080587

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K080587
Device Name	Accessories, Pump, Infusion
Applicant	ANIMAS CORP. 200 LAWRENCE DR. WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	JENNIFER BOSLEY Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2008
Decision Date	05/15/2008
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