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FDA 510(k)

HySil超快速印模材

K 號:K192941 · 2020-01-30

決定日期2020-01-30
產品代碼ELW
諮詢委員會DE
決定相當於

器材摘要

HySil Super Fast Impression Materials 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 2020-01-30 under 510(k) number K192941. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HySil Super Fast Impression Materials?

HySil Super Fast Impression Materials is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K192941.

When did HySil Super Fast Impression Materials receive FDA 510(k) clearance?

HySil Super Fast Impression Materials received FDA 510(k) clearance on 2020-01-30, under 510(k) number K192941.

Who is the listed applicant for HySil Super Fast Impression Materials?

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 HySil Super Fast Impression Materials?

The FDA product code for HySil Super Fast Impression Materials is ELW.

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其他以 Osstem Implant Co., Ltd. 為申請人之記錄

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相關器械(代碼:ELW)

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官方來源

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