FDA 510(k)

RENASYS™-WF 白色泡沫 NPWT 敷料小号；RENASYS™-WF 白色泡沫 NPWT 敷料大号

K号: K213853 · 2023-02-10

决定日期2023-02-10

产品代码OMP

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决定实质等同

器械摘要

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Medical Limited. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K213853. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large?

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Smith and Nephew Medical Limited. The 510(k) number is K213853.

When did RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large receive FDA 510(k) clearance?

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large received FDA 510(k) clearance on 2023-02-10, under 510(k) number K213853.

Who is the listed applicant for RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large?

The FDA 510(k) record lists Smith and Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large?

The FDA product code for RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large is OMP.

列明Smith and Nephew Medical Limited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。

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