FDA 510(k)

流釘

K 號：K221115 · 2022-05-13

決定日期2022-05-13

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Flow-Nail is the device name listed in this FDA 510(k) record. The listed applicant is Flow-Fx, LLC. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K221115. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flow-Nail?

Flow-Nail is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Flow-Fx, LLC. The 510(k) number is K221115.

When did Flow-Nail receive FDA 510(k) clearance?

Flow-Nail received FDA 510(k) clearance on 2022-05-13, under 510(k) number K221115.

Who is the listed applicant for Flow-Nail?

The FDA 510(k) record lists Flow-Fx, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flow-Nail?

The FDA product code for Flow-Nail is HSB.

其他以 Flow-Fx, LLC 為申請人之記錄

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K234075流釘

相關器械（代碼：HSB）

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官方來源

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