FDA 510(k) Application Details - K143280

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K143280
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	Brien Holden Vision Pty Ltd. Level 3, North Wing, RMB, Gate 14, Barker Street, UNSW Sydney 2052 AU Other 510(k) Applications for this Company
Contact	Randall May Other 510(k) Applications for this Contact
Regulation Number	886.5925   More FDA Info for this Regulation Number
Classification Product Code	LPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2014
Decision Date	04/23/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review