FDA 510(k)

Mirus 結合夾，Mirus 結合夾應用器

K 號：K200166 · 2020-11-23

申請人M/s. Meril Endo Surgery Private Limited.

決定日期2020-11-23

產品代碼FZP

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

Mirus Ligating Clip, Mirus Ligating Clip Applier is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2020-11-23 under 510(k) number K200166. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mirus Ligating Clip, Mirus Ligating Clip Applier?

Mirus Ligating Clip, Mirus Ligating Clip Applier is a medical device that received FDA 510(k) clearance on 2020-11-23. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K200166.

When did Mirus Ligating Clip, Mirus Ligating Clip Applier receive FDA 510(k) clearance?

Mirus Ligating Clip, Mirus Ligating Clip Applier received FDA 510(k) clearance on 2020-11-23, under 510(k) number K200166.

Who is the listed applicant for Mirus Ligating Clip, Mirus Ligating Clip Applier?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mirus Ligating Clip, Mirus Ligating Clip Applier?

The FDA product code for Mirus Ligating Clip, Mirus Ligating Clip Applier is FZP.

其他以 M/s. Meril Endo Surgery Private Limited. 為申請人之記錄

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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。

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