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FDA 510(k)

86 HQY SUNGLASSES

K-Number: K940705 · 1994-05-17

ApplicantFirestar, Inc.
Decision Date1994-05-17
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

86 HQY SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Firestar, Inc.. It received FDA 510(k) clearance on 1994-05-17 under 510(k) number K940705. 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 86 HQY SUNGLASSES?

86 HQY SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-05-17. The listed applicant is Firestar, Inc.. The 510(k) number is K940705.

When did 86 HQY SUNGLASSES receive FDA 510(k) clearance?

86 HQY SUNGLASSES received FDA 510(k) clearance on 1994-05-17, under 510(k) number K940705.

Who is the listed applicant for 86 HQY SUNGLASSES?

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

What is the FDA product code for 86 HQY SUNGLASSES?

The FDA product code for 86 HQY 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

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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