FDA 510(k) Application Details - K974442

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal Ball   More FDA Info for this Device
510(K) Number	K974442
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Applicant	P.T. LATEXINDO TOBAPERKASA JALAN RAYA BINJAI KM. 11. MEDAN ID Other 510(k) Applications for this Company
Contact	HENDRA RAMALI Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	LZY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/1997
Decision Date	01/05/1998
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