FDA 510(k) Application Details - K122953

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K122953
Device Name	Pump, Infusion, Insulin
Applicant	INSULET CORPORATION 9 OAK PARK DR. BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	MICHAEL J DOYLE 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	09/25/2012
Decision Date	12/07/2012
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