NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON— 510(k) K001326

Name: FDA 510(k) clearance K001326
Creator: U.S. Food and Drug Administration
Published: 2000-06-13

Substantially Equivalent

Ocular Concepts, LLC

FDA 510(k) clearance K001326 for NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON, Substantially Equivalent on 2000-06-13. Applicant: Ocular Concepts, LLC. Device class: 1.

Clearance details

Applicant: Ocular Concepts, LLC
Product code: Code NCK
Device class: Class 1
Regulation: 21 CFR 886.3200
Advisory panel: Ophthalmic
Date received: 2000-04-26
Decision date: 2000-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.