ARTIFICIAL SCLERAL SHELL— 510(k) K904961

Name: FDA 510(k) clearance K904961
Creator: U.S. Food and Drug Administration
Published: 1991-08-30

Substantially Equivalent

Midwest Eye Laboratories, Inc.

FDA 510(k) clearance K904961 for ARTIFICIAL SCLERAL SHELL, Substantially Equivalent on 1991-08-30. Applicant: Midwest Eye Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Midwest Eye Laboratories, Inc.
Product code: Code HQT
Device class: Class 2
Regulation: 21 CFR 886.3800
Advisory panel: Ophthalmic
Date received: 1990-11-05
Decision date: 1991-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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