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FDA 510(k)

SOLA UV GARD(TM) SUNGLASSES

K-Number: K870997 · 1987-05-29

ApplicantSola-Syntex Ophthalmics
Decision Date1987-05-29
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOLA UV GARD(TM) SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Sola-Syntex Ophthalmics. It received FDA 510(k) clearance on 1987-05-29 under 510(k) number K870997. 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 SOLA UV GARD(TM) SUNGLASSES?

SOLA UV GARD(TM) SUNGLASSES is a medical device that received FDA 510(k) clearance on 1987-05-29. The listed applicant is Sola-Syntex Ophthalmics. The 510(k) number is K870997.

When did SOLA UV GARD(TM) SUNGLASSES receive FDA 510(k) clearance?

SOLA UV GARD(TM) SUNGLASSES received FDA 510(k) clearance on 1987-05-29, under 510(k) number K870997.

Who is the listed applicant for SOLA UV GARD(TM) SUNGLASSES?

The FDA 510(k) record lists Sola-Syntex Ophthalmics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLA UV GARD(TM) SUNGLASSES?

The FDA product code for SOLA UV GARD(TM) SUNGLASSES is HQY.

Related Clinical Trials

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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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