FDA 510(k) Application Details - K022382

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented   More FDA Info for this Device
510(K) Number	K022382
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant	SIGNAL MEDICAL CORP. 3777 LAPEER RD. 3-C PORT HURON, MI 48060 US Other 510(k) Applications for this Company
Contact	LOUIS SERAFIN Other 510(k) Applications for this Contact
Regulation Number	888.3358   More FDA Info for this Regulation Number
Classification Product Code	LPH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2002
Decision Date	10/04/2002
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