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FDA 510(k)

SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.

K-Number: K911766 · 1991-05-22

ApplicantGall'S, Inc.
Decision Date1991-05-22
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. is the device name listed in this FDA 510(k) record. The listed applicant is Gall'S, Inc.. It received FDA 510(k) clearance on 1991-05-22 under 510(k) number K911766. 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-NONPRESCRIPTION INCLUDING PHOTOSEN.?

SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. is a medical device that received FDA 510(k) clearance on 1991-05-22. The listed applicant is Gall'S, Inc.. The 510(k) number is K911766.

When did SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. receive FDA 510(k) clearance?

SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. received FDA 510(k) clearance on 1991-05-22, under 510(k) number K911766.

Who is the listed applicant for SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.?

The FDA 510(k) record lists Gall'S, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.?

The FDA product code for SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. 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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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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