SPECTABLE FRAME - PRODESIGN SUN CLUB— 510(k) K844658

Name: FDA 510(k) clearance K844658
Creator: U.S. Food and Drug Administration
Published: 1984-12-11

Substantially Equivalent

Pro Design Intl. AS

FDA 510(k) clearance K844658 for SPECTABLE FRAME - PRODESIGN SUN CLUB, Substantially Equivalent on 1984-12-11. Applicant: Pro Design Intl. AS. Device class: 1.

Clearance details

Applicant: Pro Design Intl. AS
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1984-11-29
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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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K844657 — SPECTABLE FRAME MAGNIFYING BRILLETTE1984-12-11

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