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FDA 510(k)

霍威爾D.A.S.H.多尺寸抽吸氣球

K 號：K173659 · 2018-07-06

申請人Wilson-Cook Medical, Inc.
決定日期2018-07-06
產品代碼GCA
諮詢委員會GU
決定相當於

器材摘要

Howell D.A.S.H Extraction Balloon with Multiple Sizing is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K173659. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Howell D.A.S.H Extraction Balloon with Multiple Sizing?

Howell D.A.S.H Extraction Balloon with Multiple Sizing is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K173659.

When did Howell D.A.S.H Extraction Balloon with Multiple Sizing receive FDA 510(k) clearance?

Howell D.A.S.H Extraction Balloon with Multiple Sizing received FDA 510(k) clearance on 2018-07-06, under 510(k) number K173659.

Who is the listed applicant for Howell D.A.S.H Extraction Balloon with Multiple Sizing?

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

What is the FDA product code for Howell D.A.S.H Extraction Balloon with Multiple Sizing?

The FDA product code for Howell D.A.S.H Extraction Balloon with Multiple Sizing is GCA.

相關臨床試驗

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其他以 Wilson-Cook Medical, Inc. 為申請人之記錄

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相關器械（代碼：GCA）

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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