FDA 510(k) Application Details - K112913

Device Classification Name Retractor, Self-Retaining, For Neurosurgery

  More FDA Info for this Device
510(K) Number K112913
Device Name Retractor, Self-Retaining, For Neurosurgery
Applicant JOHNSON & JOHNSON
325 Paramount Drive
Raynham, MA 02767 US
Other 510(k) Applications for this Company
Contact LAURA BLEYENDAAL
Other 510(k) Applications for this Contact
Regulation Number 882.4800

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

  More FDA Info for this Product Code
Date Received 10/03/2011
Decision Date 12/16/2011
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