FDA 510(k) Application Details - K211575

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K211575
Device Name	Pump, Infusion, Insulin
Applicant	Insulet Corporation 100 Nagog Park Acton, MA 01720 US Other 510(k) Applications for this Company
Contact	Dennis Shay 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	05/21/2021
Decision Date	08/13/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review