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FDA 510(k)

SPECTACLE FRAMES/SUNGLASSES

K-Number: K941051 · 1994-04-12

ApplicantEuropa/Encore Eyewear
Decision Date1994-04-12
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE FRAMES/SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Europa/Encore Eyewear. It received FDA 510(k) clearance on 1994-04-12 under 510(k) number K941051. 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 SPECTACLE FRAMES/SUNGLASSES?

SPECTACLE FRAMES/SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-04-12. The listed applicant is Europa/Encore Eyewear. The 510(k) number is K941051.

When did SPECTACLE FRAMES/SUNGLASSES receive FDA 510(k) clearance?

SPECTACLE FRAMES/SUNGLASSES received FDA 510(k) clearance on 1994-04-12, under 510(k) number K941051.

Who is the listed applicant for SPECTACLE FRAMES/SUNGLASSES?

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

What is the FDA product code for SPECTACLE FRAMES/SUNGLASSES?

The FDA product code for SPECTACLE FRAMES/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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