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FDA 510(k)

FRAMES (SPECTACLES)

K-Number: K914239 · 1991-12-16

ApplicantJane Fui Optical Co., Ltd.
Decision Date1991-12-16
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FRAMES (SPECTACLES) is the device name listed in this FDA 510(k) record. The listed applicant is Jane Fui Optical Co., Ltd.. It received FDA 510(k) clearance on 1991-12-16 under 510(k) number K914239. 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 FRAMES (SPECTACLES)?

FRAMES (SPECTACLES) is a medical device that received FDA 510(k) clearance on 1991-12-16. The listed applicant is Jane Fui Optical Co., Ltd.. The 510(k) number is K914239.

When did FRAMES (SPECTACLES) receive FDA 510(k) clearance?

FRAMES (SPECTACLES) received FDA 510(k) clearance on 1991-12-16, under 510(k) number K914239.

Who is the listed applicant for FRAMES (SPECTACLES)?

The FDA 510(k) record lists Jane Fui Optical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAMES (SPECTACLES)?

The FDA product code for FRAMES (SPECTACLES) is HQZ.

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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Other records listing Jane Fui Optical Co., Ltd. as applicant

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.

K962279ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES

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.K945770OPTICAL FRAMESRamada Optics, Inc.K945392SPECTACLE FRAMESeo Han Corp., Ltd.K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.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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