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FDA 510(k)

SPECTACLE FRAMES AND SUNGLASSES

K-Number: K935974 · 1994-04-06

ApplicantPan Oceanic Eyewear
Decision Date1994-04-06
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE FRAMES AND SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Pan Oceanic Eyewear. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K935974. 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 AND SUNGLASSES?

SPECTACLE FRAMES AND SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is Pan Oceanic Eyewear. The 510(k) number is K935974.

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

SPECTACLE FRAMES AND SUNGLASSES received FDA 510(k) clearance on 1994-04-06, under 510(k) number K935974.

Who is the listed applicant for SPECTACLE FRAMES AND SUNGLASSES?

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

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

The FDA product code for SPECTACLE FRAMES AND 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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