FDA 510(k) Application Details - K040676

Device Classification Name Pump, Infusion, Insulin

  More FDA Info for this Device
510(K) Number K040676
Device Name Pump, Infusion, Insulin
Applicant MEDTRONIC MINIMED
18000 DEVONSHIRE ST.
NORTHRIDGE, CA 91325-1219 US
Other 510(k) Applications for this Company
Contact MIRIELLE MENGOTTO
Other 510(k) Applications for this Contact
Regulation Number 880.5725

  More FDA Info for this Regulation Number
Classification Product Code LZG
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/15/2004
Decision Date 05/21/2004
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



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