The following data is part of a premarket notification filed by Source Production & Equipment Co., Inc. with the FDA for Source Production & Equipment Co, Inc., Model M-19 Ir-192 Brachytherapy Source.
| Device ID | K052947 |
| 510k Number | K052947 |
| Device Name: | SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| 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 | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-20 |
| Decision Date | 2006-04-19 |
| Summary: | summary |