FDA 510(k) Application Details - K033384

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K033384
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	IMPLEX CORP. 80 COMMERCE DR. ALLENDALE, NJ 07401-1600 US Other 510(k) Applications for this Company
Contact	MARCI HALEVI Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	JDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2003
Decision Date	11/19/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review