FDA 510(k) Application Details - K970400

Device Classification Name	Implant, Malar   More FDA Info for this Device
510(K) Number	K970400
Device Name	Implant, Malar
Applicant	ORTHOFIX, INC. 250 EAST ARAPAHO RD. RICHARDSON, TX 75081 US Other 510(k) Applications for this Company
Contact	MARY BIGGERS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LZK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/1997
Decision Date	05/02/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review