FDA 510(k)

PWD Platform Wound Dressing 3” x 5” Oblong

Número K: K191460 · 2019-07-02

RequerenteApplied Tissue Technologies, LLC

Data da decisão2019-07-02

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PWD Platform Wound Dressing 3” x 5” Oblong is the device name listed in this FDA 510(k) record. The listed applicant is Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K191460. 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 PWD Platform Wound Dressing 3” x 5” Oblong?

PWD Platform Wound Dressing 3” x 5” Oblong is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K191460.

When did PWD Platform Wound Dressing 3” x 5” Oblong receive FDA 510(k) clearance?

PWD Platform Wound Dressing 3” x 5” Oblong received FDA 510(k) clearance on 2019-07-02, under 510(k) number K191460.

Who is the listed applicant for PWD Platform Wound Dressing 3” x 5” Oblong?

The FDA 510(k) record lists Applied Tissue Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong?

The FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong is OMP.

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Outros registros que listam Applied Tissue Technologies, LLC como candidato(a)

K212359PWD Negative Pressure Wound Therapy System K182409Applied Tissue Technologies PWD™ Platform Wound Dressing

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