FDA 510(k) Application Details - K171539

Device Classification Name	Case, Contact Lens   More FDA Info for this Device
510(K) Number	K171539
Device Name	Case, Contact Lens
Applicant	E-Link Plastic & Metal Industrial Co.,Ltd No.69-40, Hsing Shuh Rd. Hsing Chung Zone New Taipei 24262 CN Other 510(k) Applications for this Company
Contact	Marvis Lee 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	05/26/2017
Decision Date	07/14/2017
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