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FDA 510(k)

JAMES KOREA OPTICAL FRAMES & SUNGLASSES

K-Number: K960289 · 1996-02-16

ApplicantJames Korea Co., Ltd.
Decision Date1996-02-16
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

JAMES KOREA OPTICAL FRAMES & SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is James Korea Co., Ltd.. It received FDA 510(k) clearance on 1996-02-16 under 510(k) number K960289. 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 KOREA OPTICAL FRAMES & SUNGLASSES?

JAMES KOREA OPTICAL FRAMES & SUNGLASSES is a medical device that received FDA 510(k) clearance on 1996-02-16. The listed applicant is James Korea Co., Ltd.. The 510(k) number is K960289.

When did JAMES KOREA OPTICAL FRAMES & SUNGLASSES receive FDA 510(k) clearance?

JAMES KOREA OPTICAL FRAMES & SUNGLASSES received FDA 510(k) clearance on 1996-02-16, under 510(k) number K960289.

Who is the listed applicant for JAMES KOREA OPTICAL FRAMES & SUNGLASSES?

The FDA 510(k) record lists James Korea Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAMES KOREA OPTICAL FRAMES & SUNGLASSES?

The FDA product code for JAMES KOREA OPTICAL FRAMES & SUNGLASSES is HQY.

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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.

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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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