MENTOR HORIZON LOW VISION MAGNIFIER— 510(k) K915340

Name: FDA 510(k) clearance K915340
Creator: U.S. Food and Drug Administration
Published: 1992-03-30

Substantially Equivalent

Mentor O & O, Inc.

FDA 510(k) clearance K915340 for MENTOR HORIZON LOW VISION MAGNIFIER, Substantially Equivalent on 1992-03-30. Applicant: Mentor O & O, Inc.. Device class: 1.

Clearance details

Applicant: Mentor O & O, Inc.
Product code: Code HJG
Device class: Class 1
Regulation: 21 CFR 886.5820
Advisory panel: Ophthalmic
Date received: 1991-10-24
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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