FDA 510(k)

MTS225 and MTS300 Multiple Tray Sterilization Systems

Número K: K190541 · 2019-11-05

Data da decisão2019-11-05

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTS225 and MTS300 Multiple Tray Sterilization Systems is the device name listed in this FDA 510(k) record. The listed applicant is Pmbs, LLC. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K190541. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MTS225 and MTS300 Multiple Tray Sterilization Systems?

MTS225 and MTS300 Multiple Tray Sterilization Systems is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Pmbs, LLC. The 510(k) number is K190541.

When did MTS225 and MTS300 Multiple Tray Sterilization Systems receive FDA 510(k) clearance?

MTS225 and MTS300 Multiple Tray Sterilization Systems received FDA 510(k) clearance on 2019-11-05, under 510(k) number K190541.

Who is the listed applicant for MTS225 and MTS300 Multiple Tray Sterilization Systems?

The FDA 510(k) record lists Pmbs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS225 and MTS300 Multiple Tray Sterilization Systems?

The FDA product code for MTS225 and MTS300 Multiple Tray Sterilization Systems is KCT.

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Dispositivos Relacionados (Código: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

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