SUNGLASSES— 510(k) K974511

Substantially Equivalent

Sun World Intl., Inc.

FDA 510(k) clearance K974511 for SUNGLASSES, Substantially Equivalent on 1998-01-12. Applicant: Sun World Intl., Inc.. Device class: 1.

Clearance details

Applicant: Sun World Intl., Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-12-01
Decision date: 1998-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Square, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974441 — SUNGLASSES1998-01-09
K973528 — SUNGLASSES1997-12-08

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