The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Med-tec Testicular Separator.
| Device ID | K951679 |
| 510k Number | K951679 |
| Device Name: | MED-TEC TESTICULAR SEPARATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Contact | Donald Riibe |
| Correspondent | Donald Riibe MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-11 |
| Decision Date | 1995-07-12 |