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FDA 510(k)

棒棒糖咬阻器

K 號:K200652 · 2020-07-06

決定日期2020-07-06
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

Lollipop BiteBlock is the device name listed in this FDA 510(k) record. The listed applicant is Radtec Medical Devices, Inc.. It received FDA 510(k) clearance on 2020-07-06 under 510(k) number K200652. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lollipop BiteBlock?

Lollipop BiteBlock is a medical device that received FDA 510(k) clearance on 2020-07-06. The listed applicant is Radtec Medical Devices, Inc.. The 510(k) number is K200652.

When did Lollipop BiteBlock receive FDA 510(k) clearance?

Lollipop BiteBlock received FDA 510(k) clearance on 2020-07-06, under 510(k) number K200652.

Who is the listed applicant for Lollipop BiteBlock?

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

What is the FDA product code for Lollipop BiteBlock?

The FDA product code for Lollipop BiteBlock is IYE.

相關臨床試驗

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相關器械(代碼:IYE)

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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