The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Radionuclide Brachytherapy Source.
| Device ID | K093663 |
| 510k Number | K093663 |
| Device Name: | RADIONUCLIDE BRACHYTHERAPY SOURCE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Julie Bassett |
| Correspondent | Julie Bassett C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-25 |
| Decision Date | 2009-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741098697 | K093663 | 000 |
| 00801741078309 | K093663 | 000 |
| 00801741078293 | K093663 | 000 |
| 00801741078279 | K093663 | 000 |
| 00801741078262 | K093663 | 000 |
| 00801741078231 | K093663 | 000 |
| 00801741078224 | K093663 | 000 |
| 00801741078217 | K093663 | 000 |
| 00801741078200 | K093663 | 000 |
| 00801741078316 | K093663 | 000 |
| 00801741078323 | K093663 | 000 |
| 00801741078330 | K093663 | 000 |
| 00801741098604 | K093663 | 000 |
| 00801741098598 | K093663 | 000 |
| 00801741098376 | K093663 | 000 |
| 00801741086779 | K093663 | 000 |
| 00801741078378 | K093663 | 000 |
| 00801741078361 | K093663 | 000 |
| 00801741078354 | K093663 | 000 |
| 00801741078347 | K093663 | 000 |
| 00801741078194 | K093663 | 000 |