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FDA 510(k)

OTT SUNGLASSES

K-Number: K932135 · 1993-08-06

ApplicantSunnex Fashion Corp.
Decision Date1993-08-06
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OTT SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Sunnex Fashion Corp.. It received FDA 510(k) clearance on 1993-08-06 under 510(k) number K932135. 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 OTT SUNGLASSES?

OTT SUNGLASSES is a medical device that received FDA 510(k) clearance on 1993-08-06. The listed applicant is Sunnex Fashion Corp.. The 510(k) number is K932135.

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

OTT SUNGLASSES received FDA 510(k) clearance on 1993-08-06, under 510(k) number K932135.

Who is the listed applicant for OTT SUNGLASSES?

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

What is the FDA product code for OTT SUNGLASSES?

The FDA product code for OTT 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 Sunnex Fashion 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.

K951504SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES

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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