FDA 510(k)

Aesculap Dafilon 不吸收性聚酰胺外科縫線

K 號：K151165 · 2016-02-17

決定日期2016-02-17

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

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K151165. 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 Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture?

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Aesculap, Inc.. The 510(k) number is K151165.

When did Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture receive FDA 510(k) clearance?

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture received FDA 510(k) clearance on 2016-02-17, under 510(k) number K151165.

Who is the listed applicant for Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture?

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

What is the FDA product code for Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture?

The FDA product code for Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture is GAR.

其他以 Aesculap, Inc. 為申請人之記錄

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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。

K261484組織接合系統Tas Medical, Inc.K220980組織接合系統（TAS）Tas Medical, Inc.K212888高尼特尼龍單絲縫線Antarma, LLC Dba Golnit Sutures K212603不吸收性外科尼龍縫線Shandong Haidike Medical Product Co., Ltd.K192420Crownjun 尼龍縫線Kono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

官方來源

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