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FDA 510(k)

Compressyn™ 鋸釘

K 號:K171473 · 2017-11-07

決定日期2017-11-07
產品代碼JDR
諮詢委員會或
決定相當於

器材摘要

Compressyn™ Staple is the device name listed in this FDA 510(k) record. The listed applicant is Dallen Medical, Inc.. It received FDA 510(k) clearance on 2017-11-07 under 510(k) number K171473. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Compressyn™ Staple?

Compressyn™ Staple is a medical device that received FDA 510(k) clearance on 2017-11-07. The listed applicant is Dallen Medical, Inc.. The 510(k) number is K171473.

When did Compressyn™ Staple receive FDA 510(k) clearance?

Compressyn™ Staple received FDA 510(k) clearance on 2017-11-07, under 510(k) number K171473.

Who is the listed applicant for Compressyn™ Staple?

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

What is the FDA product code for Compressyn™ Staple?

The FDA product code for Compressyn™ Staple is JDR.

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相關器械(代碼:JDR)

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。

官方來源

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