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FDA 510(k)

CARESORB-Polyglactin 910 外科縫線，CARESORB-Polyglactin 910（快速吸收）外科縫線

K 號：K170166 · 2017-09-29

申請人Cpt Sutures Co., Ltd.
決定日期2017-09-29
產品代碼GAM
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

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Cpt Sutures Co., Ltd.. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K170166. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture?

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Cpt Sutures Co., Ltd.. The 510(k) number is K170166.

When did CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture receive FDA 510(k) clearance?

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture received FDA 510(k) clearance on 2017-09-29, under 510(k) number K170166.

Who is the listed applicant for CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture?

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

What is the FDA product code for CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture?

The FDA product code for CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture is GAM.

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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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官方來源

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