FDA 510(k)

T1-CS, T1-C 医療設備規範文本 T1-CS, T1-C 醫療設備規範文檔 T1-CS, T1-C 醫療設備註冊資料 T1-CS, T1-C FDA 認證設備 T1-CS, T1-C 510(k) 認證設備 T1-CS, T1-C PMA 認證設備 T1-CS, T1-C NCT 試驗編號 T1-CS, T1-C PMID 文獻編號 T1-CS, T1-C 識別碼 T1-CS, T1-C 網址

K 號：K183475 · 2019-08-30

決定日期2019-08-30

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

T1-CS, T1-C is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K183475. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the T1-CS, T1-C?

T1-CS, T1-C is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K183475.

When did T1-CS, T1-C receive FDA 510(k) clearance?

T1-CS, T1-C received FDA 510(k) clearance on 2019-08-30, under 510(k) number K183475.

Who is the listed applicant for T1-CS, T1-C?

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

What is the FDA product code for T1-CS, T1-C?

The FDA product code for T1-CS, T1-C is OAS.

其他以 Osstem Implant Co., Ltd. 為申請人之記錄

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