COLOR OPTIC CORNEAL EYE SHIELD— 510(k) K843961

Name: FDA 510(k) clearance K843961
Creator: U.S. Food and Drug Administration
Published: 1984-11-28

Substantially Equivalent

Colors IN Optics , Ltd.

FDA 510(k) clearance K843961 for COLOR OPTIC CORNEAL EYE SHIELD, Substantially Equivalent on 1984-11-28. Applicant: Colors IN Optics , Ltd.. Device class: 1.

Clearance details

Applicant: Colors IN Optics , Ltd.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 1984-10-11
Decision date: 1984-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarsdale, NY, US

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