FDA 510(k) Application Details - K071735

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K071735
Device Name	Pump, Infusion, Elastomeric
Applicant	SYMBIOS MEDICAL PRODUCTS, LLC 7301 GEORGETOWN RD., SUITE 150 INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	MICHAEL JAMES Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2007
Decision Date	07/19/2007
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