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FDA 510(k)

ProgenaMatrix

K 號:K182010 · 2019-01-17

決定日期2019-01-17
產品代碼KGN
決定相當於

器材摘要

ProgenaMatrix is the device name listed in this FDA 510(k) record. The listed applicant is Cell Constructs I, LLC. It received FDA 510(k) clearance on 2019-01-17 under 510(k) number K182010. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the ProgenaMatrix?

ProgenaMatrix is a medical device that received FDA 510(k) clearance on 2019-01-17. The listed applicant is Cell Constructs I, LLC. The 510(k) number is K182010.

When did ProgenaMatrix receive FDA 510(k) clearance?

ProgenaMatrix received FDA 510(k) clearance on 2019-01-17, under 510(k) number K182010.

Who is the listed applicant for ProgenaMatrix?

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

What is the FDA product code for ProgenaMatrix?

The FDA product code for ProgenaMatrix is KGN.

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相關器械(代碼:KGN)

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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