DISPOSABLE SCLERAL PLUGS— 510(k) K925671

Name: FDA 510(k) clearance K925671
Creator: U.S. Food and Drug Administration
Published: 1993-08-02

Substantially Equivalent

O.R. Specialties, Inc.

FDA 510(k) clearance K925671 for DISPOSABLE SCLERAL PLUGS, Substantially Equivalent on 1993-08-02. Applicant: O.R. Specialties, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Specialties, Inc.
Product code: Code LXP
Device class: Class 2
Regulation: 21 CFR 886.4155
Advisory panel: Ophthalmic
Date received: 1992-11-10
Decision date: 1993-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuscaloosa, AL, US

Download summary PDF View on FDA.gov ↗

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