FDA 510(k) Application Details - K182630

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K182630
Device Name	Pump, Infusion, Insulin
Applicant	Insulet Corporation 600 Technology Park Drive, Suite 200 Billerica, MA 01821 US Other 510(k) Applications for this Company
Contact	Julie Perkins 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	09/24/2018
Decision Date	01/08/2019
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