The following data is part of a premarket notification filed by Source Production & Equipment Co., Inc. with the FDA for Spec Model M-31.
| Device ID | K090366 |
| 510k Number | K090366 |
| Device Name: | SPEC MODEL M-31 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | SOURCE PRODUCTION & EQUIPMENT CO., INC. 113 TEAL STREET St. Rose, LA 70087 |
| Contact | John J Munro |
| Correspondent | John J Munro SOURCE PRODUCTION & EQUIPMENT CO., INC. 113 TEAL STREET St. 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 | 2009-02-13 |
| Decision Date | 2009-04-22 |
| Summary: | summary |