FDA 510(k)

SurFuse膠，SurFuse膠泥，ExFuse膠，ExFuse膠泥

K 號：K171568 · 2018-02-22

決定日期2018-02-22

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

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.

常見問題

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?

FDA 510(k) 記錄中將 Hans Biomed Corporation 列為申請人。這並不單獨確立該設備製造商的身份。

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.

其他以 Hans Biomed Corporation 為申請人之記錄

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相關器械（代碼：MQV）

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