FDA 510(k) Application Details - K160803

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K160803
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	CooperVision, Inc. 6150 Stoneridge Mall Rd., Suite 370 Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Roya Borazjani 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	03/23/2016
Decision Date	07/13/2016
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