FDA 510(k) Application Details - K193399

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K193399
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya 460-0006 JP Other 510(k) Applications for this Company
Contact	Li Haosheng 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	12/06/2019
Decision Date	06/17/2020
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