FDA 510(k)

LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2

Número K: K183337 · 2019-05-29

RequerenteDMG Chemisch-Pharmazeutische Fabrik GmbH

Data da decisão2019-05-29

Código do produtoEBG

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 is the device name listed in this FDA 510(k) record. The listed applicant is DMG Chemisch-Pharmazeutische Fabrik GmbH. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K183337. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2?

LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is DMG Chemisch-Pharmazeutische Fabrik GmbH. The 510(k) number is K183337.

When did LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 receive FDA 510(k) clearance?

LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 received FDA 510(k) clearance on 2019-05-29, under 510(k) number K183337.

Who is the listed applicant for LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2?

The FDA 510(k) record lists DMG Chemisch-Pharmazeutische Fabrik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2?

The FDA product code for LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 is EBG.

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Fonte oficial

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