The following data is part of a premarket notification filed by Isoray Medical, Inc. with the FDA for Proxcelan Cs-131 Preloaded Braided Strands, Model: Pl-5.
| Device ID | K092136 |
| 510k Number | K092136 |
| Device Name: | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 |
| 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 | 2009-07-15 |
| Decision Date | 2009-08-07 |
| Summary: | summary |