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FDA 510(k)

Kahook雙刀滑動(KDB滑動)

K 號:K220891 · 2024-05-17

決定日期2024-05-17
產品代碼QUQ
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

Kahook Dual Blade Glide (KDB Glide) is the device name listed in this FDA 510(k) record. The listed applicant is New World Medical, Inc.. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K220891. The device is classified under product code QUQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kahook Dual Blade Glide (KDB Glide)?

Kahook Dual Blade Glide (KDB Glide) is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is New World Medical, Inc.. The 510(k) number is K220891.

When did Kahook Dual Blade Glide (KDB Glide) receive FDA 510(k) clearance?

Kahook Dual Blade Glide (KDB Glide) received FDA 510(k) clearance on 2024-05-17, under 510(k) number K220891.

Who is the listed applicant for Kahook Dual Blade Glide (KDB Glide)?

The FDA 510(k) record lists New World Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kahook Dual Blade Glide (KDB Glide)?

The FDA product code for Kahook Dual Blade Glide (KDB Glide) is QUQ.

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其他以 New World Medical, Inc. 為申請人之記錄

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