MAGNIFYING SPECTACLES W/PLASTIC LENSES— 510(k) K844716

Name: FDA 510(k) clearance K844716
Creator: U.S. Food and Drug Administration
Published: 1985-01-03

Substantially Equivalent

Gazelle Corp.

FDA 510(k) clearance K844716 for MAGNIFYING SPECTACLES W/PLASTIC LENSES, Substantially Equivalent on 1985-01-03. Applicant: Gazelle Corp.. Device class: 1.

Clearance details

Applicant: Gazelle Corp.
Product code: Code HOI
Device class: Class 1
Regulation: 21 CFR 886.5840
Advisory panel: Ophthalmic
Date received: 1984-12-04
Decision date: 1985-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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