FDA 510(k) Application Details - K031123

Device Classification Name Catheter, Ventricular

  More FDA Info for this Device
510(K) Number K031123
Device Name Catheter, Ventricular
Applicant Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
Other 510(k) Applications for this Company
Contact ELIZABETH DOLAN
Other 510(k) Applications for this Contact
Regulation Number 882.4100

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

  More FDA Info for this Product Code
Date Received 04/09/2003
Decision Date 05/14/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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