FDA 510(k) Application Details - K092313

Device Classification Name	Pump, Infusion, Pca   More FDA Info for this Device
510(K) Number	K092313
Device Name	Pump, Infusion, Pca
Applicant	B. BRAUN MEDICAL, INC. 901 MARCON BLVD. ALLENTOWN, PA 18109-9341 US Other 510(k) Applications for this Company
Contact	SUSAN OLINGER 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	07/30/2009
Decision Date	11/04/2009
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