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FDA 510(k)

SPECTACLE FRAMES

K-Number: K935969 · 1994-02-22

ApplicantTae Kyung Optical Co., Inc.
Decision Date1994-02-22
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE FRAMES is the device name listed in this FDA 510(k) record. The listed applicant is Tae Kyung Optical Co., Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K935969. 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 SPECTACLE FRAMES?

SPECTACLE FRAMES is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Tae Kyung Optical Co., Inc.. The 510(k) number is K935969.

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

SPECTACLE FRAMES received FDA 510(k) clearance on 1994-02-22, under 510(k) number K935969.

Who is the listed applicant for SPECTACLE FRAMES?

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

What is the FDA product code for SPECTACLE FRAMES?

The FDA product code for SPECTACLE FRAMES is HQY.

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 Tae Kyung 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.

K935798MULTIPLE -SPECTACLE FRAMES/SUNGLASSES

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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