FDA 510(k)

LTJボルトおよびワッシャー

K番号: K200987 · 2020-09-22

決定日2020-09-22

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

LTJ Screws and Washer is the device name listed in this FDA 510(k) record. The listed applicant is Azurmeds, Inc.. It received FDA 510(k) clearance on 2020-09-22 under 510(k) number K200987. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the LTJ Screws and Washer?

LTJ Screws and Washer is a medical device that received FDA 510(k) clearance on 2020-09-22. The listed applicant is Azurmeds, Inc.. The 510(k) number is K200987.

When did LTJ Screws and Washer receive FDA 510(k) clearance?

LTJ Screws and Washer received FDA 510(k) clearance on 2020-09-22, under 510(k) number K200987.

Who is the listed applicant for LTJ Screws and Washer?

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

What is the FDA product code for LTJ Screws and Washer?

The FDA product code for LTJ Screws and Washer is HWC. This falls under the Cardiovascular category.

申請者としてAzurmeds, Inc.を記載するその他の記録

K210268LTJボルトおよびワッシャー

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