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FDA 510(k)

SUNGLASSES, GAUDI SUN LINE

K-Number: K962636 · 1996-07-25

ApplicantGaudi Spa
Decision Date1996-07-25
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES, GAUDI SUN LINE is the device name listed in this FDA 510(k) record. The listed applicant is Gaudi Spa. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K962636. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNGLASSES, GAUDI SUN LINE?

SUNGLASSES, GAUDI SUN LINE is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Gaudi Spa. The 510(k) number is K962636.

When did SUNGLASSES, GAUDI SUN LINE receive FDA 510(k) clearance?

SUNGLASSES, GAUDI SUN LINE received FDA 510(k) clearance on 1996-07-25, under 510(k) number K962636.

Who is the listed applicant for SUNGLASSES, GAUDI SUN LINE?

The FDA 510(k) record lists Gaudi Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNGLASSES, GAUDI SUN LINE?

The FDA product code for SUNGLASSES, GAUDI SUN LINE is HQY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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