FDA 510(k) Application Details - K051474

Device Classification Name Pump, Infusion, Elastomeric

  More FDA Info for this Device
510(K) Number K051474
Device Name Pump, Infusion, Elastomeric
Applicant SYMBIOS MEDICAL PRODUCTS, LLC
6131 WEST 80TH STREET
INDIANAPOLIS, IN 46278-1344 US
Other 510(k) Applications for this Company
Contact JEFFERY J ALHOLM
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 06/03/2005
Decision Date 07/01/2005
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact