FDA 510(k) Application Details - K130394

Device Classification Name	Pump, Infusion, Pca   More FDA Info for this Device
510(K) Number	K130394
Device Name	Pump, Infusion, Pca
Applicant	SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	PAULA CORDERO Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2013
Decision Date	12/09/2013
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