FDA 510(k) Application Details - K971479

Device Classification Name	Implant, Malar   More FDA Info for this Device
510(K) Number	K971479
Device Name	Implant, Malar
Applicant	ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 PASO ROBLES, CA 93446 US Other 510(k) Applications for this Company
Contact	GERALD HANSON 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	04/23/1997
Decision Date	07/18/1997
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