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FDA 510(k)

Mammotome 適用雙真空輔助針吸切片系統

K 號:K152989 · 2016-02-25

決定日期2016-02-25
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

Mammotome revolve Dual Vacuum Assist Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152989. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mammotome revolve Dual Vacuum Assist Biopsy System?

Mammotome revolve Dual Vacuum Assist Biopsy System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K152989.

When did Mammotome revolve Dual Vacuum Assist Biopsy System receive FDA 510(k) clearance?

Mammotome revolve Dual Vacuum Assist Biopsy System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152989.

Who is the listed applicant for Mammotome revolve Dual Vacuum Assist Biopsy System?

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

What is the FDA product code for Mammotome revolve Dual Vacuum Assist Biopsy System?

The FDA product code for Mammotome revolve Dual Vacuum Assist Biopsy System is KNW.

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其他以 Devicor Medical Products, Inc. 為申請人之記錄

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相關器械(代碼:KNW)

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官方來源

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