FDA 510(k) Application Details - K132618

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K132618
Device Name	Accessories, Pump, Infusion
Applicant	LIFESCAN, INC. 965 CHESTERBROOK BOULEVARD WAYNE, PA 19087 US Other 510(k) Applications for this Company
Contact	GABRIELLE LOGAN Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2013
Decision Date	12/16/2013
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