FDA 510(k) Application Details - K043526

Device Classification Name	Component, Cast   More FDA Info for this Device
510(K) Number	K043526
Device Name	Component, Cast
Applicant	NOBLE FIBER TECHNOLOGIES, INC. 421 SOUTH STATE ST. CLARKS SUMMIT, PA 18411 US Other 510(k) Applications for this Company
Contact	PATRICIA DAVIDSON Other 510(k) Applications for this Contact
Regulation Number	888.5940   More FDA Info for this Regulation Number
Classification Product Code	LGF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2004
Decision Date	03/10/2005
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