FDA 510(k) Application Details - K032824

Device Classification Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K032824
Device Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Applicant	STELKAST COMPANY 200 HIDDEN VALLEY ROAD MCMURRAY, PA 15317 US Other 510(k) Applications for this Company
Contact	DONALD STEVENS Other 510(k) Applications for this Contact
Regulation Number	888.3520   More FDA Info for this Regulation Number
Classification Product Code	HSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2003
Decision Date	11/13/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review