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FDA 510(k)

TheraBreath乾口口腔噴劑，TheraBreath乾口喉糖

K 號：K171542 · 2018-03-16

申請人Dr. Harold Katz, LLC (Dba Therabreath
決定日期2018-03-16
產品代碼LFD
決定相當於

器材摘要

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Harold Katz, LLC (Dba Therabreath. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K171542. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

常見問題

What is the TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Dr. Harold Katz, LLC (Dba Therabreath. The 510(k) number is K171542.

When did TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges receive FDA 510(k) clearance?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges received FDA 510(k) clearance on 2018-03-16, under 510(k) number K171542.

Who is the listed applicant for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

The FDA 510(k) record lists Dr. Harold Katz, LLC (Dba Therabreath as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

The FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is LFD.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：LFD）

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。

K253778Allday 湿潤漱口水Elevate Oral CareK250390CloSYS®乾口敏感口腔噴劑Rowpar Pharmaceuticals, Inc.K240508Salivea乾口異常保濕膠（乾口異常保濕膠）Laclede, Inc.K234015Caphosol®人工唾液（32劑包裝盒）Eusa Pharma (Uk) LimitedK231205GuruNanda乾口口腔漱口水及GuruNanda乾口口腔噴劑Gurunanda, LLCK202689Dentilube噴霧Oxy2plus, LLC

官方來源

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