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FDA PMA

人工生殖器,睪丸

PMA 核准號:P020003 · 2026-07-21

決定日期2026-07-21
PMA 編號P020003
產品代碼FAF
器械分類3 類
醫療專科G
法規編號21 CFR 8
諮詢委員會GU

器材摘要

Prosthesis, testicular is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code FAF. It was reviewed by the GU advisory panel.

常見問題

What is the Prosthesis, testicular?

Prosthesis, testicular is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Coloplast Corp..

When did Prosthesis, testicular receive FDA 510(k) clearance?

The clearance date for Prosthesis, testicular can be found in the official FDA records.

誰是假肢、睪丸檢測的登記申請人?

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

FDA產品代碼為Prosthesis, testicular的是什麼?

FDA產品代碼對於陰莖假體為 FAF。

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

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