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FDA 510(k)

雷射生髮帽

K 號:K192627 · 2019-12-13

決定日期2019-12-13
產品代碼OAP
諮詢委員會PM
決定相當於

器材摘要

Laser Hair Growth Cap is the device name listed in this FDA 510(k) record. The listed applicant is Shang FA Biotechnology Co.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192627. 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 Laser Hair Growth Cap?

Laser Hair Growth Cap is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shang FA Biotechnology Co.. The 510(k) number is K192627.

When did Laser Hair Growth Cap receive FDA 510(k) clearance?

Laser Hair Growth Cap received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192627.

Who is the listed applicant for Laser Hair Growth Cap?

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

What is the FDA product code for Laser Hair Growth Cap?

The FDA product code for Laser Hair Growth Cap is OAP.

相關臨床試驗

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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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