FDA 510(k)

IMICRYL複合材料，複合流動材料

K 號：K220077 · 2022-08-09

申請人Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

決定日期2022-08-09

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

IMICRYL Composite, Composite Flow Materials is the device name listed in this FDA 510(k) record. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2022-08-09 under 510(k) number K220077. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IMICRYL Composite, Composite Flow Materials?

IMICRYL Composite, Composite Flow Materials is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K220077.

When did IMICRYL Composite, Composite Flow Materials receive FDA 510(k) clearance?

IMICRYL Composite, Composite Flow Materials received FDA 510(k) clearance on 2022-08-09, under 510(k) number K220077.

Who is the listed applicant for IMICRYL Composite, Composite Flow Materials?

The FDA 510(k) record lists Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMICRYL Composite, Composite Flow Materials?

The FDA product code for IMICRYL Composite, Composite Flow Materials is EBF.

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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。

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官方來源

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