SYSTEMS OF SIGHT LOW VISION EYEWARE— 510(k) K854854

Name: FDA 510(k) clearance K854854
Creator: U.S. Food and Drug Administration
Published: 1986-02-04

Substantially Equivalent

Int'L Eye Care, Inc.

FDA 510(k) clearance K854854 for SYSTEMS OF SIGHT LOW VISION EYEWARE, Substantially Equivalent on 1986-02-04. Applicant: Int'L Eye Care, Inc.. Device class: 1.

Clearance details

Applicant: Int'L Eye Care, Inc.
Product code: Code HOI
Device class: Class 1
Regulation: 21 CFR 886.5840
Advisory panel: Ophthalmic
Date received: 1985-12-05
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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