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FDA 510(k)

SUNBLOCKER SUNGLASSES

K-Number: K950807 · 1995-05-24

ApplicantBlublocker Corp.
Decision Date1995-05-24
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNBLOCKER SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Blublocker Corp.. It received FDA 510(k) clearance on 1995-05-24 under 510(k) number K950807. 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 SUNBLOCKER SUNGLASSES?

SUNBLOCKER SUNGLASSES is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is Blublocker Corp.. The 510(k) number is K950807.

When did SUNBLOCKER SUNGLASSES receive FDA 510(k) clearance?

SUNBLOCKER SUNGLASSES received FDA 510(k) clearance on 1995-05-24, under 510(k) number K950807.

Who is the listed applicant for SUNBLOCKER SUNGLASSES?

The FDA 510(k) record lists Blublocker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNBLOCKER SUNGLASSES?

The FDA product code for SUNBLOCKER SUNGLASSES is HQY.

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Other records listing Blublocker Corp. 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.

K954659MOONSHADES SUNGLASSESK901160NUBALOO(R) SUNGLASSESK901161SOLAR SHADES(TM) SUNGLASSESK900381COLORVISION SUNGLASSESK900383BULLET SUNGLASSESK900382BLUBLOCKER SUNGLASSES

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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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