SUNGLASSES— 510(k) K946381

Name: FDA 510(k) clearance K946381
Creator: U.S. Food and Drug Administration
Published: 1995-02-22

Substantially Equivalent

Ialin Optical Mfg., (H.K.) Co. , Ltd.

FDA 510(k) clearance K946381 for SUNGLASSES, Substantially Equivalent on 1995-02-22. Applicant: Ialin Optical Mfg., (H.K.) Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Ialin Optical Mfg., (H.K.) Co. , Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-10-27
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yaumati, Kln., HK

Download summary PDF View on FDA.gov ↗

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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.