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FDA 510(k)

Hemostatic Dressing

K-Number: K213413 · 2023-09-01

Decision Date2023-09-01
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Hemostatic Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Newvalue Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K213413. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemostatic Dressing?

Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Jiangsu Newvalue Medical Products Co., Ltd.. The 510(k) number is K213413.

When did Hemostatic Dressing receive FDA 510(k) clearance?

Hemostatic Dressing received FDA 510(k) clearance on 2023-09-01, under 510(k) number K213413.

Who is the listed applicant for Hemostatic Dressing?

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

What is the FDA product code for Hemostatic Dressing?

The FDA product code for Hemostatic Dressing is QSY.

Other records listing Jiangsu Newvalue Medical Products 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.

Related Devices (Code: QSY)

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.