SUNGLASSES— 510(k) K971385

Substantially Equivalent

Kosway Industries Co., Ltd.

FDA 510(k) clearance K971385 for SUNGLASSES, Substantially Equivalent on 1997-07-14. Applicant: Kosway Industries Co., Ltd.. Device class: 1.

Clearance details

Applicant: Kosway Industries Co., Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-04-14
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuen Mun, N.T., HK

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
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

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