PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)— 510(k) K914407

Name: FDA 510(k) clearance K914407
Creator: U.S. Food and Drug Administration
Published: 1991-12-31

Substantially Equivalent

Promedex, Inc.

FDA 510(k) clearance K914407 for PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION), Substantially Equivalent on 1991-12-31. Applicant: Promedex, Inc.. Device class: 1.

Clearance details

Applicant: Promedex, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1991-10-02
Decision date: 1991-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, US

Download summary PDF View on FDA.gov ↗

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