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FDA 510(k)

D-Clip;D-Clip 應用器

K 號:K180757 · 2019-04-12

決定日期2019-04-12
產品代碼HCH
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

D-Clip; D-Clip Applier is the device name listed in this FDA 510(k) record. The listed applicant is Peter Lazic GmbH. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K180757. The device is classified under product code HCH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the D-Clip; D-Clip Applier?

D-Clip; D-Clip Applier is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Peter Lazic GmbH. The 510(k) number is K180757.

When did D-Clip; D-Clip Applier receive FDA 510(k) clearance?

D-Clip; D-Clip Applier received FDA 510(k) clearance on 2019-04-12, under 510(k) number K180757.

Who is the listed applicant for D-Clip; D-Clip Applier?

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

What is the FDA product code for D-Clip; D-Clip Applier?

The FDA product code for D-Clip; D-Clip Applier is HCH.

相關臨床試驗

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相關器械(代碼:HCH)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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