FDA 510(k) Application Details - K955258

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K955258
Device Name	Pump, Infusion
Applicant	SABRATEK CORP. 5601 WEST HOWARD NILES, IL 60714 US Other 510(k) Applications for this Company
Contact	CHARLES P GILL 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	11/16/1995
Decision Date	06/03/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review