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FDA 510(k)

SurgiWrap 冷凍

K 號：K200918 · 2021-01-07

申請人Mast Biosurgery
決定日期2021-01-07
產品代碼FTL
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

SurgiWrap FROST is the device name listed in this FDA 510(k) record. The listed applicant is Mast Biosurgery. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K200918. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SurgiWrap FROST?

SurgiWrap FROST is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Mast Biosurgery. The 510(k) number is K200918.

When did SurgiWrap FROST receive FDA 510(k) clearance?

SurgiWrap FROST received FDA 510(k) clearance on 2021-01-07, under 510(k) number K200918.

Who is the listed applicant for SurgiWrap FROST?

The FDA 510(k) record lists Mast Biosurgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiWrap FROST?

The FDA product code for SurgiWrap FROST is FTL.

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官方來源

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