FDA 510(k)

不吸收性外科聚酯縫線

K 號：K231183 · 2023-08-25

申請人Shandong Haidike Medical Products Co., Ltd.

決定日期2023-08-25

產品代碼GAT

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

Non absorbable Surgical Polyester Suture is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Haidike Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K231183. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Non absorbable Surgical Polyester Suture?

Non absorbable Surgical Polyester Suture is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Shandong Haidike Medical Products Co., Ltd.. The 510(k) number is K231183.

When did Non absorbable Surgical Polyester Suture receive FDA 510(k) clearance?

Non absorbable Surgical Polyester Suture received FDA 510(k) clearance on 2023-08-25, under 510(k) number K231183.

Who is the listed applicant for Non absorbable Surgical Polyester Suture?

The FDA 510(k) record lists Shandong Haidike Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non absorbable Surgical Polyester Suture?

The FDA product code for Non absorbable Surgical Polyester Suture is GAT.

其他以 Shandong Haidike Medical Products 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。

K230746不吸收性外科聚丙烯縫線 K210518外科口罩

相關器械（代碼：GAT）

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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