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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K203571
Device Name Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Applicant
Acuity Polymers, Inc.
1667 Lake Ave.,
Suite 354
Rochester,  NY  14615
Applicant Contact James A. Bonafini
Correspondent
Eyereg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Date Received12/07/2020
Decision Date 04/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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