SPECTACLE FRAMES AND SUNGLASSES— 510(k) K935974

Name: FDA 510(k) clearance K935974
Creator: U.S. Food and Drug Administration
Published: 1994-04-06

Substantially Equivalent

Pan Oceanic Eyewear

FDA 510(k) clearance K935974 for SPECTACLE FRAMES AND SUNGLASSES, Substantially Equivalent on 1994-04-06. Applicant: Pan Oceanic Eyewear. Device class: 1.

Clearance details

Applicant: Pan Oceanic Eyewear
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1993-12-13
Decision date: 1994-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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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.