DUALENZ LOW VISION EYEWEAR— 510(k) K864594

Name: FDA 510(k) clearance K864594
Creator: U.S. Food and Drug Administration
Published: 1987-01-20

Substantially Equivalent

Global Eye Care, Inc.

FDA 510(k) clearance K864594 for DUALENZ LOW VISION EYEWEAR, Substantially Equivalent on 1987-01-20. Applicant: Global Eye Care, Inc.. Device class: 1.

Clearance details

Applicant: Global Eye Care, Inc.
Product code: Code HKK
Device class: Class 1
Regulation: 21 CFR 886.5870
Advisory panel: Ophthalmic
Date received: 1986-11-21
Decision date: 1987-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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