The following data is part of a premarket notification filed by Isoray, Inc with the FDA for Cesium-131 Strand, Strand Preload, Preload, S-cartridge.
| Device ID | K062384 |
| 510k Number | K062384 |
| Device Name: | CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISORAY, INC 350 HILLS ST. SUITE 106 Richland, WA 99354 -5411 |
| Contact | David J Swanberg |
| Correspondent | David J Swanberg ISORAY, INC 350 HILLS ST. SUITE 106 Richland, WA 99354 -5411 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-15 |
| Decision Date | 2006-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011485438 | K062384 | 000 |
| 00860011485421 | K062384 | 000 |
| 00860011485414 | K062384 | 000 |
| 00860011485407 | K062384 | 000 |
| 00860000064583 | K062384 | 000 |