FDA 510(k) Application Details - K190674

Device Classification Name	Accessories, Soft Lens Products   More FDA Info for this Device
510(K) Number	K190674
Device Name	Accessories, Soft Lens Products
Applicant	Allergan, Inc 2525 Dupont Drive Irvine, CA 92623-9534 US Other 510(k) Applications for this Company
Contact	Emily Huang 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	03/15/2019
Decision Date	08/08/2019
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