NEW EYES EYEGLASS FRAME— 510(k) K940250

Name: FDA 510(k) clearance K940250
Creator: U.S. Food and Drug Administration
Published: 1994-04-19

Substantially Equivalent

Sunrise International Business

FDA 510(k) clearance K940250 for NEW EYES EYEGLASS FRAME, Substantially Equivalent on 1994-04-19. Applicant: Sunrise International Business. Device class: 1.

Clearance details

Applicant: Sunrise International Business
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-01-21
Decision date: 1994-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

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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.