FDA 510(k)

Applied Tissue Technologies PWD™ Platform Wound Dressing

Número K: K182409 · 2019-01-11

RequerenteApplied Tissue Technologies, LLC

Data da decisão2019-01-11

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Applied Tissue Technologies PWD™ Platform Wound Dressing 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 2019-01-11 under 510(k) number K182409. 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 Applied Tissue Technologies PWD™ Platform Wound Dressing?

Applied Tissue Technologies PWD™ Platform Wound Dressing is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K182409.

When did Applied Tissue Technologies PWD™ Platform Wound Dressing receive FDA 510(k) clearance?

Applied Tissue Technologies PWD™ Platform Wound Dressing received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182409.

Who is the listed applicant for Applied Tissue Technologies PWD™ Platform Wound Dressing?

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 Applied Tissue Technologies PWD™ Platform Wound Dressing?

The FDA product code for Applied Tissue Technologies PWD™ Platform Wound Dressing is OMP.

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