FDA 510(k)

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

K番号: K171568 · 2018-02-22

決定日2018-02-22

製品コードMQV

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Substantially Equivalent

医療機器の概要

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty is the device name listed in this FDA 510(k) record. The listed applicant is Hans Biomed Corporation. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171568. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty?

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Hans Biomed Corporation. The 510(k) number is K171568.

When did SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty receive FDA 510(k) clearance?

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171568.

Who is the listed applicant for SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty?

The FDA 510(k) record lists Hans Biomed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty?

The FDA product code for SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty is MQV.

申請者としてHans Biomed Corporationを記載するその他の記録

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