The following data is part of a premarket notification filed by Proxima Therapeutics, Inc. with the FDA for Gliasite Radiation Therapy System (rts), Model 1020,1030,1040,8150,9005.
| Device ID | K003206 |
| 510k Number | K003206 |
| Device Name: | GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 Alpharetta, GA 30005 -2066 |
| Contact | Deborah J Moore |
| Correspondent | Deborah J Moore PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 Alpharetta, GA 30005 -2066 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-13 |
| Decision Date | 2001-04-25 |