FDA 510(k)

Prevest Denpro 腺體洞線材（Apacal ART、Cal LC、Calcigel、CalUltra）

K 號：K212475 · 2022-05-13

決定日期2022-05-13

產品代碼EJK

諮詢委員會DE

決定相當於

器材摘要

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K212475. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Prevest Denpro Limited. The 510(k) number is K212475.

When did Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) receive FDA 510(k) clearance?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) received FDA 510(k) clearance on 2022-05-13, under 510(k) number K212475.

Who is the listed applicant for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

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

What is the FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

The FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is EJK.

其他以 Prevest Denpro Limited 為申請人之記錄

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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相關器械（代碼：EJK）

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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