FDA 510(k) Application Details - K982763

Device Classification Name	Implant, Malar   More FDA Info for this Device
510(K) Number	K982763
Device Name	Implant, Malar
Applicant	SEARE BIOMEDICAL CORP. 3190 CHULA VISTA CIRCLE SALT LAKE CITY, UT 84121 US Other 510(k) Applications for this Company
Contact	WILLIAM JOHN SEARE, JR. 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	08/06/1998
Decision Date	09/30/1998
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