FDA 510(k)

UniPrime A, UniPrime E, UniPrime E/C

Número K: K221033 · 2022-07-06

RequerenteS&C Polymer Silicon- Und Composite Spezialitäten GmbH

Data da decisão2022-07-06

Código do produtoKLE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

UniPrime A, UniPrime E, UniPrime E/C is the device name listed in this FDA 510(k) record. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitäten GmbH. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K221033. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UniPrime A, UniPrime E, UniPrime E/C?

UniPrime A, UniPrime E, UniPrime E/C is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitäten GmbH. The 510(k) number is K221033.

When did UniPrime A, UniPrime E, UniPrime E/C receive FDA 510(k) clearance?

UniPrime A, UniPrime E, UniPrime E/C received FDA 510(k) clearance on 2022-07-06, under 510(k) number K221033.

Who is the listed applicant for UniPrime A, UniPrime E, UniPrime E/C?

The FDA 510(k) record lists S&C Polymer Silicon- Und Composite Spezialitäten GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniPrime A, UniPrime E, UniPrime E/C?

The FDA product code for UniPrime A, UniPrime E, UniPrime E/C is KLE.

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