NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS— 510(k) K973016

Name: FDA 510(k) clearance K973016
Creator: U.S. Food and Drug Administration
Published: 1997-09-17

Substantially Equivalent

Optimaxx Intl.

FDA 510(k) clearance K973016 for NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS, Substantially Equivalent on 1997-09-17. Applicant: Optimaxx Intl.. Device class: 1.

Clearance details

Applicant: Optimaxx Intl.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-08-13
Decision date: 1997-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

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Recent devices under product code HQY

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K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
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.