FDA 510(k) Application Details - K071948

Device Classification Name

  More FDA Info for this Device
510(K) Number K071948
Device Name AEQUALIS REVERSED ADAPTER
Applicant TORNIER
161 RUE LAVOISIER
MONTBONNOT
SAINT-ISMIER CEDEX 38334 FR
Other 510(k) Applications for this Company
Contact Mireille Lemery
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 07/13/2007
Decision Date 10/18/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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