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FDA 510(k)

SUNGLASSES/OPTICAL FRAMES

K-Number: K854264 · 1985-11-12

Decision Date1985-11-12
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES/OPTICAL FRAMES is the device name listed in this FDA 510(k) record. The listed applicant is Wha Chun Industries, Co., Ltd.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K854264. 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/OPTICAL FRAMES?

SUNGLASSES/OPTICAL FRAMES is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Wha Chun Industries, Co., Ltd.. The 510(k) number is K854264.

When did SUNGLASSES/OPTICAL FRAMES receive FDA 510(k) clearance?

SUNGLASSES/OPTICAL FRAMES received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854264.

Who is the listed applicant for SUNGLASSES/OPTICAL FRAMES?

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

What is the FDA product code for SUNGLASSES/OPTICAL FRAMES?

The FDA product code for SUNGLASSES/OPTICAL FRAMES 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.

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.

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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