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FDA 510(k)

SPECTACLE SUN GLASSES (NON PRESCRIPTION)

K-Number: K954173 · 1995-10-03

ApplicantMonte Carlo Eyewear, Inc.
Decision Date1995-10-03
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE SUN GLASSES (NON PRESCRIPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Monte Carlo Eyewear, Inc.. It received FDA 510(k) clearance on 1995-10-03 under 510(k) number K954173. 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 SPECTACLE SUN GLASSES (NON PRESCRIPTION)?

SPECTACLE SUN GLASSES (NON PRESCRIPTION) is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is Monte Carlo Eyewear, Inc.. The 510(k) number is K954173.

When did SPECTACLE SUN GLASSES (NON PRESCRIPTION) receive FDA 510(k) clearance?

SPECTACLE SUN GLASSES (NON PRESCRIPTION) received FDA 510(k) clearance on 1995-10-03, under 510(k) number K954173.

Who is the listed applicant for SPECTACLE SUN GLASSES (NON PRESCRIPTION)?

The FDA 510(k) record lists Monte Carlo Eyewear, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTACLE SUN GLASSES (NON PRESCRIPTION)?

The FDA product code for SPECTACLE SUN GLASSES (NON PRESCRIPTION) 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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