FDA 510(k) Application Details - K983043

Device Classification Name	Implant, Muscle, Pectoralis   More FDA Info for this Device
510(K) Number	K983043
Device Name	Implant, Muscle, Pectoralis
Applicant	SEARE BIOMEDICAL CORP. 3190 CHULA VISTA CIRCLE SALT LAKE CITY, UT 84121 US Other 510(k) Applications for this Company
Contact	WILLIAM J SEARE, JR Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MIC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/1998
Decision Date	09/30/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review