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FDA 510(k)

THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES

K-Number: K924938 · 1993-04-06

ApplicantEyeworks 3
Decision Date1993-04-06
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES is the device name listed in this FDA 510(k) record. The listed applicant is Eyeworks 3. It received FDA 510(k) clearance on 1993-04-06 under 510(k) number K924938. 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 THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES?

THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES is a medical device that received FDA 510(k) clearance on 1993-04-06. The listed applicant is Eyeworks 3. The 510(k) number is K924938.

When did THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES receive FDA 510(k) clearance?

THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES received FDA 510(k) clearance on 1993-04-06, under 510(k) number K924938.

Who is the listed applicant for THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES?

The FDA 510(k) record lists Eyeworks 3 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES?

The FDA product code for THEO NON-PRESCRIPTION SUNGLASSES/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 Eyeworks 3 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.

K925736NON-PRES SUNGLASSES/SPEC FRAMES (PLASTIC & METAL)

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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