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FDA 510(k)

SUNGLASSES STYLE #(1137)

K-Number: K901570 · 1990-06-20

ApplicantZaks Stores, Inc.
Decision Date1990-06-20
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES STYLE #(1137) is the device name listed in this FDA 510(k) record. The listed applicant is Zaks Stores, Inc.. It received FDA 510(k) clearance on 1990-06-20 under 510(k) number K901570. 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 SUNGLASSES STYLE #(1137)?

SUNGLASSES STYLE #(1137) is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Zaks Stores, Inc.. The 510(k) number is K901570.

When did SUNGLASSES STYLE #(1137) receive FDA 510(k) clearance?

SUNGLASSES STYLE #(1137) received FDA 510(k) clearance on 1990-06-20, under 510(k) number K901570.

Who is the listed applicant for SUNGLASSES STYLE #(1137)?

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

What is the FDA product code for SUNGLASSES STYLE #(1137)?

The FDA product code for SUNGLASSES STYLE #(1137) 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 Zaks Stores, 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.

K901571SUNGLASSES STYLE #(CM-1989)K901572SUNGLASSES STYLE #(70116)

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.

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