FDA 510(k) Application Details - K122215

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K122215
Device Name	Pump, Infusion
Applicant	CARTICEPT MEDICAL, INC. 6120 Windward Pkwy Ste 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	07/25/2012
Decision Date	10/26/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review