FDA 510(k) Application Details - K182734

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K182734
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	UNICON Optical CO., LTD No 16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township Hsinchu County 30075 TW Other 510(k) Applications for this Company
Contact	HSIAO-WEI SHEN 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	09/28/2018
Decision Date	05/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review