The following data is part of a premarket notification filed by Bebig Isotopen-und Medizintechnik Gmbh with the FDA for Bebig Isoseed I-125.
| Device ID | K033781 |
| 510k Number | K033781 |
| Device Name: | BEBIG ISOSEED I-125 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH ROBERT-ROSSLE/STR.10 Berlin, DE 13125 |
| Contact | Sven Langer |
| Correspondent | Sven Langer BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH ROBERT-ROSSLE/STR.10 Berlin, DE 13125 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-04 |
| Decision Date | 2003-12-30 |
| Summary: | summary |