FDA 510(k) Application Details - K031373

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K031373
Device Name	Pump, Infusion, Insulin
Applicant	INSULET CORP. 100 CUMMINGS CENTER STE 239G BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	A. ARTHUR RANKIS 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	04/30/2003
Decision Date	12/19/2003
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