UVEX MINI-SPECS— 510(k) K813548

Name: FDA 510(k) clearance K813548
Creator: U.S. Food and Drug Administration
Published: 1982-03-02

Substantially Equivalent

Bacou USA, Inc. and Uvex Safety, Inc.

FDA 510(k) clearance K813548 for UVEX MINI-SPECS, Substantially Equivalent on 1982-03-02. Applicant: Bacou USA, Inc. and Uvex Safety, Inc.. Device class: 1.

Clearance details

Applicant: Bacou USA, Inc. and Uvex Safety, Inc.
Product code: Code HOI
Device class: Class 1
Regulation: 21 CFR 886.5840
Advisory panel: Ophthalmic
Date received: 1981-12-21
Decision date: 1982-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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