SUNGLASSES (NON-PRESCRIPTION)— 510(k) K935114

Name: FDA 510(k) clearance K935114
Creator: U.S. Food and Drug Administration
Published: 1994-02-22

Substantially Equivalent

Promising Enterprise CO , Ltd.

FDA 510(k) clearance K935114 for SUNGLASSES (NON-PRESCRIPTION), Substantially Equivalent on 1994-02-22. Applicant: Promising Enterprise CO , Ltd.. Device class: 1.

Clearance details

Applicant: Promising Enterprise CO , Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1993-10-25
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan, TW

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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.