LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE— 510(k) K933633

Name: FDA 510(k) clearance K933633
Creator: U.S. Food and Drug Administration
Published: 1994-02-22

Substantially Equivalent

Gracefully Yours, Inc.

FDA 510(k) clearance K933633 for LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE, Substantially Equivalent on 1994-02-22. Applicant: Gracefully Yours, Inc.. Device class: 1.

Clearance details

Applicant: Gracefully Yours, Inc.
Product code: Code HJG
Device class: Class 1
Regulation: 21 CFR 886.5820
Advisory panel: Ophthalmic
Date received: 1993-07-27
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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