The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Brachysource Brachytherapy Seed Implants.
| Device ID | K043246 |
| 510k Number | K043246 |
| Device Name: | BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30014 |
| Contact | John C Knorpp |
| Correspondent | John C Knorpp C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30014 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-23 |
| Decision Date | 2005-02-02 |
| Summary: | summary |