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FDA 510(k)

FRAME, SPECTACLE

K-Number: K945450 · 1994-11-22

ApplicantKookje Apis Industrial Co.
Decision Date1994-11-22
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FRAME, SPECTACLE is the device name listed in this FDA 510(k) record. The listed applicant is Kookje Apis Industrial Co.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K945450. 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 FRAME, SPECTACLE?

FRAME, SPECTACLE is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Kookje Apis Industrial Co.. The 510(k) number is K945450.

When did FRAME, SPECTACLE receive FDA 510(k) clearance?

FRAME, SPECTACLE received FDA 510(k) clearance on 1994-11-22, under 510(k) number K945450.

Who is the listed applicant for FRAME, SPECTACLE?

The FDA 510(k) record lists Kookje Apis Industrial Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAME, SPECTACLE?

The FDA product code for FRAME, SPECTACLE 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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