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PMA de la FDA

Sealant, polymerizing

Número de PMA: P100030 · 2025-07-10

SolicitanteBaxter Healthcare Corporation
Fecha de decisión2025-07-10
Número PMAP100030
Código de productoNBE
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Sealant, polymerizing is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2025-07-10. The device is classified under product code NBE. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Sealant, polymerizing?

Sealant, polymerizing is a medical device that received FDA 510(k) clearance on 2025-07-10. The listed applicant is Baxter Healthcare Corporation.

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 Healthcare Corporation 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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Fuente oficial

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