The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Med-tec Hand Grip.
| Device ID | K954225 |
| 510k Number | K954225 |
| Device Name: | MED-TEC HAND GRIP |
| Classification | Table, Radiographic, Stationary Top |
| Applicant | MEDTEC, INC. P.O. BOX 487 1401 8TH STREET SOUTH EAST Orange City, IA 51041 -0487 |
| Contact | Donald F Riibe |
| Correspondent | Donald F Riibe MEDTEC, INC. P.O. BOX 487 1401 8TH STREET SOUTH EAST Orange City, IA 51041 -0487 |
| Product Code | IXQ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-11 |
| Decision Date | 1995-11-14 |