FDA 510(k) Application Details - K190045

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K190045
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 US Other 510(k) Applications for this Company
Contact	Heather Smith 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	01/09/2019
Decision Date	02/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review