FDA 510(k) Application Details - K162869

Device Classification Name	Case, Contact Lens   More FDA Info for this Device
510(K) Number	K162869
Device Name	Case, Contact Lens
Applicant	Ningbo Yinzhou Zonghai Artware Co., Ltd. Honglianchi, Guangsheng Village, Jishigang Town Yinzhou District Ningbo City 315172 CN Other 510(k) Applications for this Company
Contact	Weng Changhai Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2016
Decision Date	12/09/2016
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