FDA 510(k)

INNO SLA 潜植入系統

K 號：K201323 · 2022-01-25

決定日期2022-01-25

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

INNO SLA Submerged Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2022-01-25 under 510(k) number K201323. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INNO SLA Submerged Implant System?

INNO SLA Submerged Implant System is a medical device that received FDA 510(k) clearance on 2022-01-25. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K201323.

When did INNO SLA Submerged Implant System receive FDA 510(k) clearance?

INNO SLA Submerged Implant System received FDA 510(k) clearance on 2022-01-25, under 510(k) number K201323.

Who is the listed applicant for INNO SLA Submerged Implant System?

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

What is the FDA product code for INNO SLA Submerged Implant System?

The FDA product code for INNO SLA Submerged Implant System is NHA.

其他以 Cowellmedi Co., Ltd. 為申請人之記錄

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相關器械（代碼：NHA）

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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