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FDA 510(k)

結腸加長型、小號及直型水套

K 號:K180800 · 2018-06-01

申請人Colonic Plus
決定日期2018-06-01
產品代碼KPL
諮詢委員會GU
決定Unknown

器材摘要

Colonic Plus Regular, Small, and Straight Shape Hydrokit is the device name listed in this FDA 510(k) record. The listed applicant is Colonic Plus. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180800. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Colonic Plus Regular, Small, and Straight Shape Hydrokit?

Colonic Plus Regular, Small, and Straight Shape Hydrokit is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Colonic Plus. The 510(k) number is K180800.

When did Colonic Plus Regular, Small, and Straight Shape Hydrokit receive FDA 510(k) clearance?

Colonic Plus Regular, Small, and Straight Shape Hydrokit received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180800.

Who is the listed applicant for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

The FDA 510(k) record lists Colonic Plus as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

The FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit is KPL.

相關臨床試驗

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相關器械(代碼:KPL)

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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