FDA 510(k) Application Details - K003543

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K003543
Device Name	Pump, Infusion
Applicant	STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	NICOLE PETTY 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	11/17/2000
Decision Date	06/05/2001
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