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.
| Device ID | K163206 |
| 510k Number | K163206 |
| Device Name: | SMD-Sr90-DA Radionuclide Brachytherapy Source |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | Salutaris Medical Devices, Inc. 4330 N Campbell Ave, Suite 266 Tucson, AZ 85718 |
| Contact | Laurence Marsteller |
| Correspondent | Laurence Marsteller Salutaris Medical Devices, Inc. 4330 N Campbell Ave, Suite 266 Tucson, AZ 85718 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-15 |
| Decision Date | 2016-12-15 |