SMD-Sr90-DA Radionuclide Brachytherapy Source— 510(k) K163206
Substantially EquivalentSalutaris Medical Devices, Inc.
FDA 510(k) clearance K163206 for SMD-Sr90-DA Radionuclide Brachytherapy Source, Substantially Equivalent on 2016-12-15. Applicant: Salutaris Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Salutaris Medical Devices, Inc.
- Product code
- Code KXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
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