The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for 360 Deg. Rotating 1/2 Beam Block.
| Device ID | K941719 |
| 510k Number | K941719 |
| Device Name: | 360 DEG. ROTATING 1/2 BEAM BLOCK |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 Orange City, IA 51041 |
| Contact | Donald Riibe |
| Correspondent | Donald Riibe MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 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 | 1994-04-07 |
| Decision Date | 1994-07-18 |