Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VARIOUS SUNGLASSES (NON-PRESCRIPTION)

K-Number: K963890 · 1996-11-19

ApplicantItalian Eyewear, Inc.
Decision Date1996-11-19
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VARIOUS SUNGLASSES (NON-PRESCRIPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Italian Eyewear, Inc.. It received FDA 510(k) clearance on 1996-11-19 under 510(k) number K963890. 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 VARIOUS SUNGLASSES (NON-PRESCRIPTION)?

VARIOUS SUNGLASSES (NON-PRESCRIPTION) is a medical device that received FDA 510(k) clearance on 1996-11-19. The listed applicant is Italian Eyewear, Inc.. The 510(k) number is K963890.

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

VARIOUS SUNGLASSES (NON-PRESCRIPTION) received FDA 510(k) clearance on 1996-11-19, under 510(k) number K963890.

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

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

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

The FDA product code for VARIOUS SUNGLASSES (NON-PRESCRIPTION) 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

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.

↑