FDA 510(k) Application Details - K061824

Device Classification Name	Cement Obturator   More FDA Info for this Device
510(K) Number	K061824
Device Name	Cement Obturator
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	878.3300   More FDA Info for this Regulation Number
Classification Product Code	LZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2006
Decision Date	09/14/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review