SUNGLASSES, GAUDI SUN LINE— 510(k) K962636

Substantially Equivalent

Gaudi Spa

FDA 510(k) clearance K962636 for SUNGLASSES, GAUDI SUN LINE, Substantially Equivalent on 1996-07-25. Applicant: Gaudi Spa. Device class: 1.

Clearance details

Applicant: Gaudi Spa
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1996-07-05
Decision date: 1996-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oviedo, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

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.