NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES— 510(k) K941053

Name: FDA 510(k) clearance K941053
Creator: U.S. Food and Drug Administration
Published: 1994-07-12

Substantially Equivalent

Hsin Chen Intl. Co., Ltd.

FDA 510(k) clearance K941053 for NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES, Substantially Equivalent on 1994-07-12. Applicant: Hsin Chen Intl. Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hsin Chen Intl. Co., Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-03-03
Decision date: 1994-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Taiwan, TW

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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.