FDA 510(k) Application Details - K031249

Device Classification Name Pump, Infusion

  More FDA Info for this Device
510(K) Number K031249
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 04/18/2003
Decision Date 07/21/2003
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