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FDA 510(k)

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

K 號：K161996 · 2017-02-16

申請人Amend Surgical, Inc.
決定日期2017-02-16
產品代碼MQV
諮詢委員會或
決定相當於

器材摘要

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is the device name listed in this FDA 510(k) record. The listed applicant is Amend Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K161996. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Amend Surgical, Inc.. The 510(k) number is K161996.

When did 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE receive FDA 510(k) clearance?

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE received FDA 510(k) clearance on 2017-02-16, under 510(k) number K161996.

Who is the listed applicant for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?

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

What is the FDA product code for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?

The FDA product code for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is MQV.

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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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