FDA 510(k)

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

Número K: K161897 · 2016-10-04

RequerenteKci USA, Inc. (Kinetic Concepts, Inc.)

Data da decisão2016-10-04

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K161897. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K161897.

When did PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings receive FDA 510(k) clearance?

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161897.

Who is the listed applicant for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

The FDA 510(k) record lists Kci USA, Inc. (Kinetic Concepts, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

The FDA product code for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is OMP.

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