SUNGLASSES— 510(k) K943562

Substantially Equivalent

Australian Optical Co., Inc.

FDA 510(k) clearance K943562 for SUNGLASSES, Substantially Equivalent on 1994-09-14. Applicant: Australian Optical Co., Inc.. Device class: 1.

Clearance details

Applicant: Australian Optical Co., Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-07-22
Decision date: 1994-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

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K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

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