FDA 510(k) Application Details - K213164

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K213164
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	CooperVision. Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 US Other 510(k) Applications for this Company
Contact	Ahanitha Ashok 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	09/28/2021
Decision Date	10/26/2021
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