FDA 510(k) Application Details - K201194

Device Classification Name	Lens, Contact (Other Material) - Daily   More FDA Info for this Device
510(K) Number	K201194
Device Name	Lens, Contact (Other Material) - Daily
Applicant	Acuity Polymers, Inc. 1667 Lake Avenue, Suite 354 Rochester, NY 14615 US Other 510(k) Applications for this Company
Contact	James A. Bonafini Other 510(k) Applications for this Contact
Regulation Number	886.5916   More FDA Info for this Regulation Number
Classification Product Code	HQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2020
Decision Date	09/08/2020
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