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FDA 510(k)

OPTICAL FRAME

K-Number: K910179 · 1991-04-10

ApplicantAustralian Optical Co., Inc.
Decision Date1991-04-10
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTICAL FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Australian Optical Co., Inc.. It received FDA 510(k) clearance on 1991-04-10 under 510(k) number K910179. 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 OPTICAL FRAME?

OPTICAL FRAME is a medical device that received FDA 510(k) clearance on 1991-04-10. The listed applicant is Australian Optical Co., Inc.. The 510(k) number is K910179.

When did OPTICAL FRAME receive FDA 510(k) clearance?

OPTICAL FRAME received FDA 510(k) clearance on 1991-04-10, under 510(k) number K910179.

Who is the listed applicant for OPTICAL FRAME?

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

What is the FDA product code for OPTICAL FRAME?

The FDA product code for OPTICAL FRAME is HQZ.

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Other records listing Australian Optical Co., Inc. 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.

K943562SUNGLASSESK943641SPECTACLE FRAMEK943561SPECTACLE FRAMEK943640SUNGLASS CLIPK935678SUNGLASS FRAMEK930331SPECTACLE FRAME

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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