THE ULTRA-MATE LENS— 510(k) K854218

Name: FDA 510(k) clearance K854218
Creator: U.S. Food and Drug Administration
Published: 1985-11-12

Substantially Equivalent

Optical Systems Intl., Inc.

FDA 510(k) clearance K854218 for THE ULTRA-MATE LENS, Substantially Equivalent on 1985-11-12. Applicant: Optical Systems Intl., Inc.. Device class: 1.

Clearance details

Applicant: Optical Systems Intl., Inc.
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1985-10-17
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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