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FDA 510(k)

膠原P.I.N.(經皮誘導釘刺)

K 號:K222199 · 2022-10-21

決定日期2022-10-21
產品代碼QAI
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Collagen P.I.N. (Percutaneous Induction Needling) is the device name listed in this FDA 510(k) record. The listed applicant is Induction Therapies, LLC. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K222199. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Collagen P.I.N. (Percutaneous Induction Needling)?

Collagen P.I.N. (Percutaneous Induction Needling) is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Induction Therapies, LLC. The 510(k) number is K222199.

When did Collagen P.I.N. (Percutaneous Induction Needling) receive FDA 510(k) clearance?

Collagen P.I.N. (Percutaneous Induction Needling) received FDA 510(k) clearance on 2022-10-21, under 510(k) number K222199.

Who is the listed applicant for Collagen P.I.N. (Percutaneous Induction Needling)?

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

What is the FDA product code for Collagen P.I.N. (Percutaneous Induction Needling)?

The FDA product code for Collagen P.I.N. (Percutaneous Induction Needling) is QAI.

相關臨床試驗

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相關器械(代碼:QAI)

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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