The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Uni-frame Head Immobilization System.
| Device ID | K933227 |
| 510k Number | K933227 |
| Device Name: | UNI-FRAME HEAD IMMOBILIZATION SYSTEM |
| 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 | 1993-07-02 |
| Decision Date | 1994-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439103173 | K933227 | 000 |
| 00841439104958 | K933227 | 000 |
| 00841439104965 | K933227 | 000 |
| 00841439106266 | K933227 | 000 |
| 00841439107089 | K933227 | 000 |
| 00841439110232 | K933227 | 000 |
| 00841439110294 | K933227 | 000 |
| 00841439103555 | K933227 | 000 |
| 00841439103739 | K933227 | 000 |
| 00841439104934 | K933227 | 000 |
| 00841439104163 | K933227 | 000 |
| 00841439102015 | K933227 | 000 |
| 00841439102039 | K933227 | 000 |
| 00841439102381 | K933227 | 000 |
| 00841439102398 | K933227 | 000 |
| 00841439102404 | K933227 | 000 |
| 00841439104125 | K933227 | 000 |
| 00841439104132 | K933227 | 000 |
| 00841439104156 | K933227 | 000 |
| 00841439103760 | K933227 | 000 |
| 00841439108864 | K933227 | 000 |
| 00841439107133 | K933227 | 000 |
| 00841439107195 | K933227 | 000 |
| 00841439107201 | K933227 | 000 |
| 00841439107638 | K933227 | 000 |
| 00841439107645 | K933227 | 000 |
| 00841439111338 | K933227 | 000 |
| 00841439111345 | K933227 | 000 |
| 00841439103159 | K933227 | 000 |
| 00841439107096 | K933227 | 000 |
| 00841439106990 | K933227 | 000 |
| 00841439102442 | K933227 | 000 |
| 00841439104118 | K933227 | 000 |
| 00841439104927 | K933227 | 000 |
| 00841439104941 | K933227 | 000 |
| 00841439106501 | K933227 | 000 |
| 00841439106518 | K933227 | 000 |
| 00841439106525 | K933227 | 000 |
| 00841439106532 | K933227 | 000 |
| 00841439104101 | K933227 | 000 |