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FDA 510(k)

SUNGLASSES

K-Number: K864543 · 1987-03-13

ApplicantImage of Hawaii
Decision Date1987-03-13
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Image of Hawaii. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K864543. 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?

SUNGLASSES is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Image of Hawaii. The 510(k) number is K864543.

When did SUNGLASSES receive FDA 510(k) clearance?

SUNGLASSES received FDA 510(k) clearance on 1987-03-13, under 510(k) number K864543.

Who is the listed applicant for SUNGLASSES?

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

What is the FDA product code for SUNGLASSES?

The FDA product code for SUNGLASSES 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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