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FDA 510(k)

髮龍69

K 號:K182562 · 2018-11-16

申請人Wontech
決定日期2018-11-16
產品代碼OAP
諮詢委員會PM
決定相當於

器材摘要

Hair Boom 69 is the device name listed in this FDA 510(k) record. The listed applicant is Wontech. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K182562. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hair Boom 69?

Hair Boom 69 is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Wontech. The 510(k) number is K182562.

When did Hair Boom 69 receive FDA 510(k) clearance?

Hair Boom 69 received FDA 510(k) clearance on 2018-11-16, under 510(k) number K182562.

Who is the listed applicant for Hair Boom 69?

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

What is the FDA product code for Hair Boom 69?

The FDA product code for Hair Boom 69 is OAP.

其他以 Wontech 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。

相關器械(代碼:OAP)

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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