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FDA 510(k)

SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)

K-Number: K952438 · 1995-09-12

ApplicantTaiwan Eva Industrial Co., Inc.
Decision Date1995-09-12
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Eva Industrial Co., Inc.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K952438. 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 SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)?

SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Taiwan Eva Industrial Co., Inc.. The 510(k) number is K952438.

When did SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) receive FDA 510(k) clearance?

SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) received FDA 510(k) clearance on 1995-09-12, under 510(k) number K952438.

Who is the listed applicant for SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)?

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

What is the FDA product code for SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)?

The FDA product code for SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 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 Taiwan Eva Industrial 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.

K945351SHIELD, EYE, OPHTHALMICK945350FRAME, SPECTACLES

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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