FDA 510(k)

Theia NPWT 泡沫傷口敷料組合包

K 號：K211277 · 2021-12-16

決定日期2021-12-16

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Theia NPWT Foam Wound Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Clear Choice Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K211277. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Theia NPWT Foam Wound Dressing Kit?

Theia NPWT Foam Wound Dressing Kit is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Clear Choice Therapeutics, Inc.. The 510(k) number is K211277.

When did Theia NPWT Foam Wound Dressing Kit receive FDA 510(k) clearance?

Theia NPWT Foam Wound Dressing Kit received FDA 510(k) clearance on 2021-12-16, under 510(k) number K211277.

Who is the listed applicant for Theia NPWT Foam Wound Dressing Kit?

The FDA 510(k) record lists Clear Choice Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Theia NPWT Foam Wound Dressing Kit?

The FDA product code for Theia NPWT Foam Wound Dressing Kit is OMP.

相關器械（代碼：OMP）

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器材摘要

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相關臨床試驗

相關器械（代碼：OMP）

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