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FDA 510(k)

D'ARC EYE CARE SUNGLASSES

K-Number: K972490 · 1997-07-25

ApplicantM & R Dist.
Decision Date1997-07-25
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

D'ARC EYE CARE SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is M & R Dist.. It received FDA 510(k) clearance on 1997-07-25 under 510(k) number K972490. 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 D'ARC EYE CARE SUNGLASSES?

D'ARC EYE CARE SUNGLASSES is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is M & R Dist.. The 510(k) number is K972490.

When did D'ARC EYE CARE SUNGLASSES receive FDA 510(k) clearance?

D'ARC EYE CARE SUNGLASSES received FDA 510(k) clearance on 1997-07-25, under 510(k) number K972490.

Who is the listed applicant for D'ARC EYE CARE SUNGLASSES?

The FDA 510(k) record lists M & R Dist. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D'ARC EYE CARE SUNGLASSES?

The FDA product code for D'ARC EYE CARE SUNGLASSES is HQY.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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