SPECTACLE FRAMES— 510(k) K943442

Name: FDA 510(k) clearance K943442
Creator: U.S. Food and Drug Administration
Published: 1994-08-02

Substantially Equivalent

Sunny Union Industrial Co., Ltd.

FDA 510(k) clearance K943442 for SPECTACLE FRAMES, Substantially Equivalent on 1994-08-02. Applicant: Sunny Union Industrial Co., Ltd.. Device class: 1.

Clearance details

Applicant: Sunny Union Industrial Co., Ltd.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1994-07-18
Decision date: 1994-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES1994-12-15
K945392 — SPECTACLE FRAME1994-12-15
K945770 — OPTICAL FRAMES1994-12-15

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K943443 — SUNGLASSES1994-08-02

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