OPTI-FREE EXPRESS LENS DROPS— 510(k) K000385

Name: FDA 510(k) clearance K000385
Creator: U.S. Food and Drug Administration
Published: 2000-04-28

Substantially Equivalent

Alcon Universal, Ltd.

FDA 510(k) clearance K000385 for OPTI-FREE EXPRESS LENS DROPS, Substantially Equivalent on 2000-04-28. Applicant: Alcon Universal, Ltd.. Device class: 2.

Clearance details

Applicant: Alcon Universal, Ltd.
Product code: Code MRC
Device class: Class 2
Regulation: 21 CFR 886.5918
Advisory panel: Ophthalmic
Date received: 2000-02-07
Decision date: 2000-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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