The following data is part of a premarket notification filed by Proxima Therapeutics, Inc. with the FDA for Mammosite Radiation Therapy System (rts) Tray, Mammosite Hdr Afterloader Accessories Tray.
| Device ID | K032067 |
| 510k Number | K032067 |
| Device Name: | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 Alpharetta, GA 30005 -2066 |
| Contact | Martine D Schneider |
| Correspondent | Martine D Schneider PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 Alpharetta, GA 30005 -2066 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-03 |
| Decision Date | 2004-02-10 |
| Summary: | summary |