FDA 510(k)

FiteBac 抗菌牙洞清潔劑

K 號：K200614 · 2020-06-25

決定日期2020-06-25

產品代碼LBH

諮詢委員會DE

決定相當於

器材摘要

FiteBac Antimicrobial Cavity Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Largent Health, LLC. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K200614. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FiteBac Antimicrobial Cavity Cleanser?

FiteBac Antimicrobial Cavity Cleanser is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is Largent Health, LLC. The 510(k) number is K200614.

When did FiteBac Antimicrobial Cavity Cleanser receive FDA 510(k) clearance?

FiteBac Antimicrobial Cavity Cleanser received FDA 510(k) clearance on 2020-06-25, under 510(k) number K200614.

Who is the listed applicant for FiteBac Antimicrobial Cavity Cleanser?

The FDA 510(k) record lists Largent Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FiteBac Antimicrobial Cavity Cleanser?

The FDA product code for FiteBac Antimicrobial Cavity Cleanser is LBH.

其他以 Largent Health, LLC 為申請人之記錄

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。

K210115FiteBac CC 正骨密封 K190271FiteBac 腔道清潔劑

相關器械（代碼：LBH）

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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