The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Gammamed 212 And 232 Source Assembly.
| Device ID | K030745 |
| 510k Number | K030745 |
| Device Name: | GAMMAMED 212 AND 232 SOURCE ASSEMBLY |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | VARIAN MEDICAL SYSTEMS 700 HARRIS STREET SUITE 109 Charlottesville, VA 22903 -1038 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS 700 HARRIS STREET SUITE 109 Charlottesville, VA 22903 -1038 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-10 |
| Decision Date | 2003-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389028838 | K030745 | 000 |