FDA 510(k) Application Details - K161548

Device Classification Name	Prosthesis, Nose, Internal   More FDA Info for this Device
510(K) Number	K161548
Device Name	Prosthesis, Nose, Internal
Applicant	SOUTHERN IMPLANTS (PTY) LTD. 1 ALBERT STREET CENTURION 0062 ZA Other 510(k) Applications for this Company
Contact	LAURANDA BREYTENBACH 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	06/03/2016
Decision Date	12/01/2016
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