FDA 510(k) Application Details - K012052

Device Classification Name Shunt, Central Nervous System And Components

  More FDA Info for this Device
510(K) Number K012052
Device Name Shunt, Central Nervous System And Components
Applicant MEDTRONIC PS MEDICAL
125 CREMONA DR.
GOLETA, CA 93117-5500 US
Other 510(k) Applications for this Company
Contact JEFF HENDERSON
Other 510(k) Applications for this Contact
Regulation Number 882.5550

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

  More FDA Info for this Product Code
Date Received 07/02/2001
Decision Date 02/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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