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FDA 510(k)

InnoSEAL 止血垫

K号: K161013 · 2016-11-29

决定日期2016-11-29
产品代码QSY
决定实质等同

器械摘要

InnoSEAL Hemostatic Pad is the device name listed in this FDA 510(k) record. The listed applicant is Innotherapy, Inc.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) number K161013. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the InnoSEAL Hemostatic Pad?

InnoSEAL Hemostatic Pad is a medical device that received FDA 510(k) clearance on 2016-11-29. The listed applicant is Innotherapy, Inc.. The 510(k) number is K161013.

When did InnoSEAL Hemostatic Pad receive FDA 510(k) clearance?

InnoSEAL Hemostatic Pad received FDA 510(k) clearance on 2016-11-29, under 510(k) number K161013.

Who is the listed applicant for InnoSEAL Hemostatic Pad?

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

What is the FDA product code for InnoSEAL Hemostatic Pad?

The FDA product code for InnoSEAL Hemostatic Pad 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。

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