FDA 510(k)

gel-e Bandage

Número K: K172010 · 2017-12-07

RequerenteGel-E, Inc. (Formerly Remedium Technologies, Inc.)

Data da decisão2017-12-07

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

gel-e Bandage is the device name listed in this FDA 510(k) record. The listed applicant is Gel-E, Inc. (Formerly Remedium Technologies, Inc.). It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K172010. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the gel-e Bandage?

gel-e Bandage is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Gel-E, Inc. (Formerly Remedium Technologies, Inc.). The 510(k) number is K172010.

When did gel-e Bandage receive FDA 510(k) clearance?

gel-e Bandage received FDA 510(k) clearance on 2017-12-07, under 510(k) number K172010.

Who is the listed applicant for gel-e Bandage?

The FDA 510(k) record lists Gel-E, Inc. (Formerly Remedium Technologies, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gel-e Bandage?

The FDA product code for gel-e Bandage is KGN.

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