FDA 510(k)

Adesivo Tópico de Pele ACTABOND

Número K: K161050 · 2016-10-04

Data da decisão2016-10-04

Código do produtoMPN

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ACTABOND Topical Skin Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Bergen Medical Products, Inc.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K161050. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ACTABOND Topical Skin Adhesive?

ACTABOND Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Bergen Medical Products, Inc.. The 510(k) number is K161050.

When did ACTABOND Topical Skin Adhesive receive FDA 510(k) clearance?

ACTABOND Topical Skin Adhesive received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161050.

Who is the listed applicant for ACTABOND Topical Skin Adhesive?

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

What is the FDA product code for ACTABOND Topical Skin Adhesive?

The FDA product code for ACTABOND Topical Skin Adhesive is MPN.

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