The following data is part of a premarket notification filed by Isoray Medical, Inc. with the FDA for Proxcelan Cs-131preloaded Strands, Model Pl-1, Proxcelan Cs-131 Preloaded Strands In 18 Guage Needles, Model Pl-2.
| Device ID | K092458 |
| 510k Number | K092458 |
| Device Name: | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISORAY MEDICAL, INC. 350 HILLS ST., SUITE 106 Richland, WA 99354 -5411 |
| Contact | Fred Swindler |
| Correspondent | Fred Swindler ISORAY MEDICAL, 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 | 2009-08-11 |
| Decision Date | 2009-08-28 |
| Summary: | summary |