FDA 510(k)

NovoSorb Matrix

K号: K221686 · 2022-09-15

决定日期2022-09-15

产品代码QSZ

决定实质等同

器械摘要

NovoSorb Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Polynovo Biomaterials Pty, Ltd.. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K221686. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常见问题

What is the NovoSorb Matrix?

NovoSorb Matrix is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K221686.

When did NovoSorb Matrix receive FDA 510(k) clearance?

NovoSorb Matrix received FDA 510(k) clearance on 2022-09-15, under 510(k) number K221686.

Who is the listed applicant for NovoSorb Matrix?

The FDA 510(k) record lists Polynovo Biomaterials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoSorb Matrix?

The FDA product code for NovoSorb Matrix is QSZ.

列明Polynovo Biomaterials Pty, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251567NovoSorb BTM K242149NovoSorb® MTX K172140NovoSorb BTM 创面敷料（2cm x 2cm），NovoSorb BTM 创面敷料（10cm x 10cm），NovoSorb BTM 创面敷料（10cm x 20cm），NovoSorb BTM 创面敷料（20cm x 40cm）

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