SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2— 510(k) K910597

Name: FDA 510(k) clearance K910597
Creator: U.S. Food and Drug Administration
Published: 1991-04-26

Substantially Equivalent

Radix Group Intl.

FDA 510(k) clearance K910597 for SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2, Substantially Equivalent on 1991-04-26. Applicant: Radix Group Intl.. Device class: 1.

Clearance details

Applicant: Radix Group Intl.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1991-02-12
Decision date: 1991-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

view all

K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.