The following data is part of a premarket notification filed by Source Production And Equipment Co., Inc. with the FDA for Source Production & Equipment Co., Inc. Model M14 192iridium Brachytherapy Source.
| Device ID | K162573 |
| 510k Number | K162573 |
| Device Name: | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source |
| 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 | 2016-09-15 |
| Decision Date | 2016-11-04 |
| Summary: | summary |