FDA 510(k) Application Details - K160482

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K160482
Device Name	Pump, Infusion, Insulin
Applicant	Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Michael Sarrasin 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	02/22/2016
Decision Date	07/13/2016
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