FDA 510(k)

UNFOLDER Vitan Inserter

Número K: K191949 · 2019-09-13

RequerenteJohnson & Johnson Surgical Vision, Inc.

Data da decisão2019-09-13

Código do produtoMSS

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

UNFOLDER Vitan Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K191949. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UNFOLDER Vitan Inserter?

UNFOLDER Vitan Inserter is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K191949.

When did UNFOLDER Vitan Inserter receive FDA 510(k) clearance?

UNFOLDER Vitan Inserter received FDA 510(k) clearance on 2019-09-13, under 510(k) number K191949.

Who is the listed applicant for UNFOLDER Vitan Inserter?

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

What is the FDA product code for UNFOLDER Vitan Inserter?

The FDA product code for UNFOLDER Vitan Inserter is MSS.

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Dispositivos Relacionados (Código: MSS)

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Fonte oficial

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