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FDA 510(k)

SUNGLASSES & SPORT SUNGLASSES

K-Number: K952963 · 1995-09-12

ApplicantWenzhou Winsor Optical International Co., Ltd.
Decision Date1995-09-12
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES & SPORT SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Winsor Optical International Co., Ltd.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K952963. 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 & SPORT SUNGLASSES?

SUNGLASSES & SPORT SUNGLASSES is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Wenzhou Winsor Optical International Co., Ltd.. The 510(k) number is K952963.

When did SUNGLASSES & SPORT SUNGLASSES receive FDA 510(k) clearance?

SUNGLASSES & SPORT SUNGLASSES received FDA 510(k) clearance on 1995-09-12, under 510(k) number K952963.

Who is the listed applicant for SUNGLASSES & SPORT SUNGLASSES?

The FDA 510(k) record lists Wenzhou Winsor Optical International Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNGLASSES & SPORT SUNGLASSES?

The FDA product code for SUNGLASSES & SPORT SUNGLASSES is HQY.

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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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