The following data is part of a premarket notification filed by Bebig Isotopen-und Medizintechnik Gmbh with the FDA for Brachytherapy Strand Device.
| Device ID | K040339 |
| 510k Number | K040339 |
| Device Name: | BRACHYTHERAPY STRAND DEVICE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-11 |
| Decision Date | 2004-04-08 |
| Summary: | summary |