NON-PRESCRIPTION SUNGLASSES— 510(k) K941186

Name: FDA 510(k) clearance K941186
Creator: U.S. Food and Drug Administration
Published: 1994-05-17

Substantially Equivalent

Sungold Ent. , Ltd.

FDA 510(k) clearance K941186 for NON-PRESCRIPTION SUNGLASSES, Substantially Equivalent on 1994-05-17. Applicant: Sungold Ent. , Ltd.. Device class: 1.

Clearance details

Applicant: Sungold Ent. , Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-03-14
Decision date: 1994-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

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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.