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FDA 510(k)

JAMES ALEX SUNGLASSES

K-Number: K970101 · 1997-03-04

ApplicantD&K Stores, Inc.
Decision Date1997-03-04
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

JAMES ALEX SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is D&K Stores, Inc.. It received FDA 510(k) clearance on 1997-03-04 under 510(k) number K970101. 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 JAMES ALEX SUNGLASSES?

JAMES ALEX SUNGLASSES is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is D&K Stores, Inc.. The 510(k) number is K970101.

When did JAMES ALEX SUNGLASSES receive FDA 510(k) clearance?

JAMES ALEX SUNGLASSES received FDA 510(k) clearance on 1997-03-04, under 510(k) number K970101.

Who is the listed applicant for JAMES ALEX SUNGLASSES?

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

What is the FDA product code for JAMES ALEX SUNGLASSES?

The FDA product code for JAMES ALEX 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.

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Other records listing D&K 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.

K960798D & K SUNGLASSESK960797D & K 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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