FDA 510(k) Application Details - K161931

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K161931
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	POLYDEV LTD. TINURE RD COLLON IE Other 510(k) Applications for this Company
Contact	JOHN MULVIHILL 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	07/14/2016
Decision Date	10/12/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review