FDA 510(k) Application Details - K061439

Device Classification Name	More FDA Info for this Device
510(K) Number	K061439
Device Name	AEQUALIS REVERSED PROSTHESIS
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	05/24/2006
Decision Date	07/20/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review