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FDA 510(k)

SUNGLASS FRAME

K-Number: K935678 · 1994-02-16

ApplicantAustralian Optical Co., Inc.
Decision Date1994-02-16
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASS 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 1994-02-16 under 510(k) number K935678. 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 SUNGLASS FRAME?

SUNGLASS FRAME is a medical device that received FDA 510(k) clearance on 1994-02-16. The listed applicant is Australian Optical Co., Inc.. The 510(k) number is K935678.

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

SUNGLASS FRAME received FDA 510(k) clearance on 1994-02-16, under 510(k) number K935678.

Who is the listed applicant for SUNGLASS 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 SUNGLASS FRAME?

The FDA product code for SUNGLASS FRAME is HQY.

Related Clinical Trials

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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.

K943641SPECTACLE FRAMEK943562SUNGLASSESK943561SPECTACLE FRAMEK943640SUNGLASS CLIPK930331SPECTACLE FRAMEK911332SPECTACLE FRAME

View all 8 devices →

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

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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