OPTIMUM WETTING AND REWETTING DROP— 510(k) K001428

Name: FDA 510(k) clearance K001428
Creator: U.S. Food and Drug Administration
Published: 2000-05-26

Substantially Equivalent

Lobob Laboratories, Inc.

FDA 510(k) clearance K001428 for OPTIMUM WETTING AND REWETTING DROP, Substantially Equivalent on 2000-05-26. Applicant: Lobob Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Lobob Laboratories, Inc.
Product code: Code MRC
Device class: Class 2
Regulation: 21 CFR 886.5918
Advisory panel: Ophthalmic
Date received: 2000-05-05
Decision date: 2000-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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