FDA 510(k)

PANAVIA SA 結石通用

K 號：K183537 · 2019-04-25

決定日期2019-04-25

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

PANAVIA SA Cement Universal is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K183537. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PANAVIA SA Cement Universal?

PANAVIA SA Cement Universal is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K183537.

When did PANAVIA SA Cement Universal receive FDA 510(k) clearance?

PANAVIA SA Cement Universal received FDA 510(k) clearance on 2019-04-25, under 510(k) number K183537.

Who is the listed applicant for PANAVIA SA Cement Universal?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANAVIA SA Cement Universal?

The FDA product code for PANAVIA SA Cement Universal is EMA.

其他以 Kuraray Noritake Dental, Inc. 為申請人之記錄

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相關器械（代碼：EMA）

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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