FDA 510(k)

Flexi-Seal PROTECT Fecal Management System

K-번호: K162906 · 2017-03-07

결정일2017-03-07

제품 코드KNT

자문 위원회GU

결정Substantially Equivalent

기기 요약

Flexi-Seal PROTECT Fecal Management System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec. It received FDA 510(k) clearance on 2017-03-07 under 510(k) number K162906. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Flexi-Seal PROTECT Fecal Management System?

Flexi-Seal PROTECT Fecal Management System is a medical device that received FDA 510(k) clearance on 2017-03-07. The listed applicant is Convatec. The 510(k) number is K162906.

When did Flexi-Seal PROTECT Fecal Management System receive FDA 510(k) clearance?

Flexi-Seal PROTECT Fecal Management System received FDA 510(k) clearance on 2017-03-07, under 510(k) number K162906.

Who is the listed applicant for Flexi-Seal PROTECT Fecal Management System?

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

What is the FDA product code for Flexi-Seal PROTECT Fecal Management System?

The FDA product code for Flexi-Seal PROTECT Fecal Management System is KNT.

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