FDA 510(k)

Crownjun 尼龍縫線

K 號：K192420 · 2020-05-29

決定日期2020-05-29

產品代碼GAR

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

Crownjun Nylon Suture is the device name listed in this FDA 510(k) record. The listed applicant is Kono Seisakusho Co., Ltd.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K192420. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Crownjun Nylon Suture?

Crownjun Nylon Suture is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Kono Seisakusho Co., Ltd.. The 510(k) number is K192420.

When did Crownjun Nylon Suture receive FDA 510(k) clearance?

Crownjun Nylon Suture received FDA 510(k) clearance on 2020-05-29, under 510(k) number K192420.

Who is the listed applicant for Crownjun Nylon Suture?

The FDA 510(k) record lists Kono Seisakusho Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Crownjun Nylon Suture?

The FDA product code for Crownjun Nylon Suture is GAR.

其他以 Kono Seisakusho Co., Ltd. 為申請人之記錄

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。

K230281皮科夾

相關器械（代碼：GAR）

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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官方來源

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