FDA 510(k) Application Details - K974807

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal   More FDA Info for this Device
510(K) Number	K974807
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant	OSTEONICS CORP. 59 ROUTE 17 ALLENDALE, NJ 07401-1677 US Other 510(k) Applications for this Company
Contact	TERRY SHERIDAN Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	KWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1997
Decision Date	03/16/1998
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