The following data is part of a premarket notification filed by Med-tec,inc. with the FDA for Electron Wedge Model Mt-ew-1000.
| Device ID | K981992 |
| 510k Number | K981992 |
| Device Name: | ELECTRON WEDGE MODEL MT-EW-1000 |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | MED-TEC,INC. 1401 8TH ST. S.E. P.O. BOX 320 Orange City, IA 51041 |
| Contact | Donald F Riibe |
| Correspondent | Donald F Riibe MED-TEC,INC. 1401 8TH ST. S.E. P.O. BOX 320 Orange City, IA 51041 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-08 |
| Decision Date | 1998-12-15 |