FDA 510(k) Application Details - K191872

Device Classification Name	Accessories, Soft Lens Products   More FDA Info for this Device
510(K) Number	K191872
Device Name	Accessories, Soft Lens Products
Applicant	Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya 460-0006 JP Other 510(k) Applications for this Company
Contact	Tetsuji Kawai Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2019
Decision Date	03/02/2020
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