PLASTIC SUNGLASSES— 510(k) K964316

Name: FDA 510(k) clearance K964316
Creator: U.S. Food and Drug Administration
Published: 1996-12-17

Substantially Equivalent

Medical Reports Exchange, Inc.

FDA 510(k) clearance K964316 for PLASTIC SUNGLASSES, Substantially Equivalent on 1996-12-17. Applicant: Medical Reports Exchange, Inc.. Device class: 1.

Clearance details

Applicant: Medical Reports Exchange, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1996-10-29
Decision date: 1996-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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.