FDA 510(k)

Reperen Surgical Mesh

Número K: K170134 · 2017-08-09

Data da decisão2017-08-09

Código do produtoFTL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reperen Surgical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Iconlab, Inc.. It received FDA 510(k) clearance on 2017-08-09 under 510(k) number K170134. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reperen Surgical Mesh?

Reperen Surgical Mesh is a medical device that received FDA 510(k) clearance on 2017-08-09. The listed applicant is Iconlab, Inc.. The 510(k) number is K170134.

When did Reperen Surgical Mesh receive FDA 510(k) clearance?

Reperen Surgical Mesh received FDA 510(k) clearance on 2017-08-09, under 510(k) number K170134.

Who is the listed applicant for Reperen Surgical Mesh?

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

What is the FDA product code for Reperen Surgical Mesh?

The FDA product code for Reperen Surgical Mesh is FTL.

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