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FDA 510(k)

NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES

K-Number: K953627 · 1995-10-25

ApplicantNew Sun Optical Enterprise Co., Ltd.
Decision Date1995-10-25
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is New Sun Optical Enterprise Co., Ltd.. It received FDA 510(k) clearance on 1995-10-25 under 510(k) number K953627. 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 NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES?

NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES is a medical device that received FDA 510(k) clearance on 1995-10-25. The listed applicant is New Sun Optical Enterprise Co., Ltd.. The 510(k) number is K953627.

When did NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES receive FDA 510(k) clearance?

NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES received FDA 510(k) clearance on 1995-10-25, under 510(k) number K953627.

Who is the listed applicant for NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES?

The FDA 510(k) record lists New Sun Optical Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES?

The FDA product code for NEW SUN OPTICAL NON PRESCRIPTION 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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