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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 K180988
Device Name Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
Applicant
Acuity Polymers, Inc.
1667 Lake Avenue, Suite 354
Rochester,  NY  14615
Applicant Contact James A. Bonafini
Correspondent
Acuity Polymers, Inc.
1667 Lake Avenue, Suite 354
Rochester,  NY  14615
Correspondent Contact James A. Bonafini
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/16/2018
Decision Date 06/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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