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FDA 510(k)

Collagen Wound Dressing

K-Number: K231152 · 2023-10-12

Decision Date2023-10-12
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K231152. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Collagen Wound Dressing?

Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K231152.

When did Collagen Wound Dressing receive FDA 510(k) clearance?

Collagen Wound Dressing received FDA 510(k) clearance on 2023-10-12, under 510(k) number K231152.

Who is the listed applicant for Collagen Wound Dressing?

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

What is the FDA product code for Collagen Wound Dressing?

The FDA product code for Collagen Wound Dressing is KGN.

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.

Other records listing Winner Medical Co., Ltd. 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.

View all 18 devices →

Related Devices (Code: KGN)

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.