Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens— 510(k) K170007

Substantially Equivalent

Acuity Polymers, Inc.

FDA 510(k) clearance K170007 for Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2017-05-31. Applicant: Acuity Polymers, Inc..

Clearance details

Applicant: Acuity Polymers, Inc.
Product code: Code HQD
Advisory panel: Ophthalmic
Date received: 2017-01-03
Decision date: 2017-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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