人工乳房，充氣式，內置，鹽水
PMA 核准號：P120011 · 2025-02-11
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決定日期2025-02-11
PMA 編號P120011
產品代碼FWM
器械分類3 類
醫療專科G
法規編號21 CFR 8
諮詢委員會SU
請提供完整的描述文本，以便我進行翻譯。
器材摘要
Prosthesis, breast, inflatable, internal, saline is the device name listed in this FDA 510(k) record. The listed applicant is Bimini Health Tech. It received FDA 510(k) clearance on 2025-02-11. The device is classified under product code FWM. It was reviewed by the SU advisory panel.
常見問題
What is the Prosthesis, breast, inflatable, internal, saline?
Prosthesis, breast, inflatable, internal, saline is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Bimini Health Tech.
When did Prosthesis, breast, inflatable, internal, saline receive FDA 510(k) clearance?
The clearance date for Prosthesis, breast, inflatable, internal, saline can be found in the official FDA records.
Who is the listed applicant for Prosthesis, breast, inflatable, internal, saline?
The FDA 510(k) record lists Bimini Health Tech as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Prosthesis, breast, inflatable, internal, saline?
The FDA product code for Prosthesis, breast, inflatable, internal, saline is FWM.
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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