FDA 510(k) Application Details - K002434

Device Classification Name	Pump, Infusion, Pca   More FDA Info for this Device
510(K) Number	K002434
Device Name	Pump, Infusion, Pca
Applicant	SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH WEST JORDAN, UT 84088-8320 US Other 510(k) Applications for this Company
Contact	R. DOUGLAS JACOB 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	08/09/2000
Decision Date	08/23/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review