FDA 510(k) Application Details - K112067

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K112067
Device Name	Pump, Infusion
Applicant	CARTICEPT MEDICAL INC 6120 WINDWARD PRKWY SUITE 220 ALPHARETTA, GA 30005 US Other 510(k) Applications for this Company
Contact	Tanya Eberle Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2011
Decision Date	09/16/2011
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