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FDA 510(k)

LIBCO SUNGLASSES

K-Number: K801196 · 1980-05-28

ApplicantLibco Eyewear, Inc.
Decision Date1980-05-28
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LIBCO SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Libco Eyewear, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K801196. 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 LIBCO SUNGLASSES?

LIBCO SUNGLASSES is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Libco Eyewear, Inc.. The 510(k) number is K801196.

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

LIBCO SUNGLASSES received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801196.

Who is the listed applicant for LIBCO SUNGLASSES?

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

What is the FDA product code for LIBCO SUNGLASSES?

The FDA product code for LIBCO SUNGLASSES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Libco Eyewear, Inc. 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.

K791112LIBCO 1,2,3, EYEGLASS FRAMES

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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