The following data is part of a premarket notification filed by Source Production And Equipment Co.,inc. with the FDA for Spec Model M13.
| Device ID | K161395 |
| 510k Number | K161395 |
| Device Name: | SPEC Model M13 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | Source Production And Equipment Co.,Inc. 113 Teal Street Saint Rose, LA 70087 |
| Contact | Kelley Richardt |
| Correspondent | Kelley Richardt Source Production And Equipment Co.,Inc. 113 Teal Street Saint Rose, LA 70087 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-19 |
| Decision Date | 2016-07-06 |
| Summary: | summary |