The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Palladium-103 Seed Implant Kits -multiple.
| Device ID | K060636 |
| 510k Number | K060636 |
| Device Name: | PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Contact | Julie J Bassett |
| Correspondent | Julie J Bassett C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-10 |
| Decision Date | 2006-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741098703 | K060636 | 000 |
| 00801741078521 | K060636 | 000 |
| 00801741078514 | K060636 | 000 |
| 00801741078507 | K060636 | 000 |
| 00801741078491 | K060636 | 000 |
| 00801741078446 | K060636 | 000 |
| 00801741078439 | K060636 | 000 |
| 00801741078422 | K060636 | 000 |
| 00801741078415 | K060636 | 000 |
| 00801741078538 | K060636 | 000 |
| 00801741078545 | K060636 | 000 |
| 00801741098666 | K060636 | 000 |
| 00801741098659 | K060636 | 000 |
| 00801741098642 | K060636 | 000 |
| 00801741098635 | K060636 | 000 |
| 00801741098628 | K060636 | 000 |
| 00801741091353 | K060636 | 000 |
| 00801741086786 | K060636 | 000 |
| 00801741078552 | K060636 | 000 |
| 00801741078408 | K060636 | 000 |