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FDA 510(k)

Hydris™ 口腔噴劑

K 號:K163029 · 2017-06-19

決定日期2017-06-19
產品代碼LFD
決定相當於

器材摘要

Hydris™ Oral Rinse is the device name listed in this FDA 510(k) record. The listed applicant is Biopharm Consult, LLC. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K163029. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

常見問題

What is the Hydris™ Oral Rinse?

Hydris™ Oral Rinse is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Biopharm Consult, LLC. The 510(k) number is K163029.

When did Hydris™ Oral Rinse receive FDA 510(k) clearance?

Hydris™ Oral Rinse received FDA 510(k) clearance on 2017-06-19, under 510(k) number K163029.

Who is the listed applicant for Hydris™ Oral Rinse?

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

What is the FDA product code for Hydris™ Oral Rinse?

The FDA product code for Hydris™ Oral Rinse is LFD.

相關臨床試驗

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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。

官方來源

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