FDA 510(k) Application Details - K033425

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K033425
Device Name	Pump, Infusion
Applicant	SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH WEST JORDAN, UT 84088-8320 US Other 510(k) Applications for this Company
Contact	Douglas Bueschel 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	10/27/2003
Decision Date	11/06/2003
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