ITEM # 755 HOT SUNGLASSES— 510(k) K931055

Name: FDA 510(k) clearance K931055
Creator: U.S. Food and Drug Administration
Published: 1993-10-01

Substantially Equivalent

South American Industrial Co.

FDA 510(k) clearance K931055 for ITEM # 755 HOT SUNGLASSES, Substantially Equivalent on 1993-10-01. Applicant: South American Industrial Co.. Device class: 1.

Clearance details

Applicant: South American Industrial Co.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1993-02-11
Decision date: 1993-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, 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.