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FDA 510(k)

SUNGLASSES AND SPORT SUNGLASSES

K-Number: K941076 · 1994-04-12

Applicant20/20 Ent.
Decision Date1994-04-12
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES AND SPORT SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is 20/20 Ent.. It received FDA 510(k) clearance on 1994-04-12 under 510(k) number K941076. 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 AND SPORT SUNGLASSES?

SUNGLASSES AND SPORT SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-04-12. The listed applicant is 20/20 Ent.. The 510(k) number is K941076.

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

SUNGLASSES AND SPORT SUNGLASSES received FDA 510(k) clearance on 1994-04-12, under 510(k) number K941076.

Who is the listed applicant for SUNGLASSES AND SPORT SUNGLASSES?

The FDA 510(k) record lists 20/20 Ent. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for SUNGLASSES AND 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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