FDA 510(k) Application Details - K132146

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K132146
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	ST. SHINE OPTICAL CO., LTD. 4,5 F/L NO. 276-2 SEC. 1 TATUNG RD.,HSICHIN CITY TAIPEI HSIEN 221 TW Other 510(k) Applications for this Company
Contact	ELLA LEE 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	07/11/2013
Decision Date	08/30/2013
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