FDA 510(k)

帕克爾自粘合膠泥

K 號：K210259 · 2022-01-20

決定日期2022-01-20

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

Parkell Self-Adhesive Cement is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K210259. 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 Parkell Self-Adhesive Cement?

Parkell Self-Adhesive Cement is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Parkell, Inc.. The 510(k) number is K210259.

When did Parkell Self-Adhesive Cement receive FDA 510(k) clearance?

Parkell Self-Adhesive Cement received FDA 510(k) clearance on 2022-01-20, under 510(k) number K210259.

Who is the listed applicant for Parkell Self-Adhesive Cement?

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

What is the FDA product code for Parkell Self-Adhesive Cement?

The FDA product code for Parkell Self-Adhesive Cement is EMA.

其他以 Parkell, 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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