ILWAIT TIMER OCULOPRESSOR— 510(k) K112952

Name: FDA 510(k) clearance K112952
Creator: U.S. Food and Drug Administration
Published: 2012-05-10

Substantially Equivalent

Oryx Medical Pty, Ltd.

FDA 510(k) clearance K112952 for ILWAIT TIMER OCULOPRESSOR, Substantially Equivalent on 2012-05-10. Applicant: Oryx Medical Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Oryx Medical Pty, Ltd.
Product code: Code LCC
Device class: Class 2
Regulation: 21 CFR 886.4610
Advisory panel: Ophthalmic
Date received: 2011-10-05
Decision date: 2012-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maylands, AT

Download summary PDF View on FDA.gov ↗

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