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FDA 510(k)

止血疏水凝胶海绵

K号: K192671 · 2020-08-28

决定日期2020-08-28
产品代码QSY
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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相关器械(代码:QSY)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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