FDA 510(k) Application Details - K982753

Device Classification Name	Prosthesis, Nose, Internal   More FDA Info for this Device
510(K) Number	K982753
Device Name	Prosthesis, Nose, Internal
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	878.3680   More FDA Info for this Regulation Number
Classification Product Code	FZE 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