The following data is part of a premarket notification filed by Symtium Corporation with the FDA for Mod1 Compensators For Radiation Beam Therapy.
| Device ID | K062781 |
| 510k Number | K062781 |
| Device Name: | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | SYMTIUM CORPORATION 11503 JONES MALTSBERGER SUITE 710 San Antonio, TX 78216 |
| Contact | Sean Comer |
| Correspondent | Sean Comer SYMTIUM CORPORATION 11503 JONES MALTSBERGER SUITE 710 San Antonio, TX 78216 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-11-21 |
| Summary: | summary |