FDA 510(k) Application Details - K082783

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K082783
Device Name	Accessories, Pump, Infusion
Applicant	SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	PHIL NEURURER 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	09/23/2008
Decision Date	12/17/2008
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