The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Med-tec String Reticle Tray.
| Device ID | K951601 |
| 510k Number | K951601 |
| Device Name: | MED-TEC STRING RETICLE TRAY |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 Orange City, IA 51041 |
| Contact | Donald F Riibe |
| Correspondent | Donald F Riibe MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 Orange City, IA 51041 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-05-11 |