FDA 510(k) Application Details - K141758

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K141758
Device Name	Pump, Infusion, Insulin
Applicant	TANDEM DIABETES CARE, INC. 1835 MARKET STREET, 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE HOGAN 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	06/30/2014
Decision Date	10/31/2014
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