SMD-Sr90-DA Radionuclide Brachytherapy Source

Source, Brachytherapy, Radionuclide

Salutaris Medical Devices, Inc.

The following data is part of a premarket notification filed by Salutaris Medical Devices, Inc. with the FDA for Smd-sr90-da Radionuclide Brachytherapy Source.

Pre-market Notification Details

Device IDK163206
510k NumberK163206
Device Name:SMD-Sr90-DA Radionuclide Brachytherapy Source
ClassificationSource, Brachytherapy, Radionuclide
Applicant Salutaris Medical Devices, Inc. 4330 N Campbell Ave, Suite 266 Tucson,  AZ  85718
ContactLaurence Marsteller
CorrespondentLaurence Marsteller
Salutaris Medical Devices, Inc. 4330 N Campbell Ave, Suite 266 Tucson,  AZ  85718
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-15
Decision Date2016-12-15

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