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FDA 510(k)

止血性乾燥凝胶膠布

K 號:K192671 · 2020-08-28

決定日期2020-08-28
產品代碼QSY
決定相當於

器材摘要

Hemostatic Xerogel Sponge is the device name listed in this FDA 510(k) record. The listed applicant is Solaplus Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K192671. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常見問題

What is the Hemostatic Xerogel Sponge?

Hemostatic Xerogel Sponge is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Solaplus Biotech Co., Ltd.. The 510(k) number is K192671.

When did Hemostatic Xerogel Sponge receive FDA 510(k) clearance?

Hemostatic Xerogel Sponge received FDA 510(k) clearance on 2020-08-28, under 510(k) number K192671.

Who is the listed applicant for Hemostatic Xerogel Sponge?

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

What is the FDA product code for Hemostatic Xerogel Sponge?

The FDA product code for Hemostatic Xerogel Sponge is QSY.

相關臨床試驗

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相關器械(代碼:QSY)

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。

官方來源

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