FDA PMA

Sealant, polymerizing

Número do PMA: P030039 · 2025-12-18

RequerenteBaxter Bio Science

Data da decisão2025-12-18

Número PMAP030039

Código do produtoNBE

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do dispositivo

Sealant, polymerizing is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Bio Science. It received FDA 510(k) clearance on 2025-12-18. The device is classified under product code NBE. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Sealant, polymerizing?

Sealant, polymerizing is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Baxter Bio Science.

When did Sealant, polymerizing receive FDA 510(k) clearance?

The clearance date for Sealant, polymerizing can be found in the official FDA records.

Who is the listed applicant for Sealant, polymerizing?

The FDA 510(k) record lists Baxter Bio Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sealant, polymerizing?

The FDA product code for Sealant, polymerizing is NBE.

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