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Found 2 results

510(k) Data Aggregation

K Number

Device Name

SMD-Sr90-DA Radionuclide Brachytherapy Source

Manufacturer

Salutaris Medical Devices, Inc.

Date Cleared

2016-12-15

(30 days)

Product Code

KXK

Regulation Number

892.5730

Why did this record match?

Applicant Name (Manufacturer) :

Salutaris Medical Devices, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The SMD-Sr90-DA Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy. The SMD-Sr90-DA RBS device is intended for use within a manual brachytherapy applicator system.

Device Description

Not Found

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K Number

Device Name

SMD Sr90-1 Radionuclide Brachytherapy Source

Manufacturer

Salutaris Medical Devices, Inc.

Date Cleared

2014-12-19

(88 days)

Product Code

KXK

Regulation Number

892.5730

Why did this record match?

Applicant Name (Manufacturer) :

Salutaris Medical Devices, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The SMD Sr90-1 Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy of tumors and benign growths. The SMD Sr90-1 RBS device is intended for use within a manual brachytherapy applicator system.

Device Description

Not Found

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