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FDA 510(k)

SPECTACLE SUNGLASSES(NON-PRESCRIPTION)

K-Number: K953629 · 1995-08-23

ApplicantLowinger Holdings, Inc.
Decision Date1995-08-23
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE SUNGLASSES(NON-PRESCRIPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Lowinger Holdings, Inc.. It received FDA 510(k) clearance on 1995-08-23 under 510(k) number K953629. 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 SUNGLASSES(NON-PRESCRIPTION)?

SPECTACLE SUNGLASSES(NON-PRESCRIPTION) is a medical device that received FDA 510(k) clearance on 1995-08-23. The listed applicant is Lowinger Holdings, Inc.. The 510(k) number is K953629.

When did SPECTACLE SUNGLASSES(NON-PRESCRIPTION) receive FDA 510(k) clearance?

SPECTACLE SUNGLASSES(NON-PRESCRIPTION) received FDA 510(k) clearance on 1995-08-23, under 510(k) number K953629.

Who is the listed applicant for SPECTACLE SUNGLASSES(NON-PRESCRIPTION)?

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

What is the FDA product code for SPECTACLE SUNGLASSES(NON-PRESCRIPTION)?

The FDA product code for SPECTACLE SUNGLASSES(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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