The following data is part of a premarket notification filed by Isoray, Inc with the FDA for Lawrence Cserion, Model Cs-1.
| Device ID | K030162 |
| 510k Number | K030162 |
| Device Name: | LAWRENCE CSERION, MODEL CS-1 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISORAY, INC 350 HILLS ST. SUITE 106 Richland, WA 99352 |
| Contact | David Swanberg |
| Correspondent | David Swanberg ISORAY, INC 350 HILLS ST. SUITE 106 Richland, WA 99352 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-16 |
| Decision Date | 2003-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000064576 | K030162 | 000 |
| 00860000064569 | K030162 | 000 |