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FDA 510(k)

OPHTHALMIC EYEWEAR

K-Number: K821391 · 1982-06-29

ApplicantNordic Eyewear, Inc.
Decision Date1982-06-29
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC EYEWEAR is the device name listed in this FDA 510(k) record. The listed applicant is Nordic Eyewear, Inc.. It received FDA 510(k) clearance on 1982-06-29 under 510(k) number K821391. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC EYEWEAR?

OPHTHALMIC EYEWEAR is a medical device that received FDA 510(k) clearance on 1982-06-29. The listed applicant is Nordic Eyewear, Inc.. The 510(k) number is K821391.

When did OPHTHALMIC EYEWEAR receive FDA 510(k) clearance?

OPHTHALMIC EYEWEAR received FDA 510(k) clearance on 1982-06-29, under 510(k) number K821391.

Who is the listed applicant for OPHTHALMIC EYEWEAR?

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

What is the FDA product code for OPHTHALMIC EYEWEAR?

The FDA product code for OPHTHALMIC EYEWEAR is HQZ.

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Related Devices (Code: HQZ)

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.

K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.K945392SPECTACLE FRAMESeo Han Corp., Ltd.K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.K945770OPTICAL FRAMESRamada Optics, Inc.K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.

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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