The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Vac-lok Immobilization System.
| Device ID | K935300 |
| 510k Number | K935300 |
| Device Name: | VAC-LOK 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 | 1993-11-02 |
| Decision Date | 1994-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439108529 | K935300 | 000 |
| 00841439108512 | K935300 | 000 |
| 00841439107225 | K935300 | 000 |
| 00841439107232 | K935300 | 000 |
| 00841439108697 | K935300 | 000 |
| 00841439108710 | K935300 | 000 |
| 00841439108734 | K935300 | 000 |
| 00841439108758 | K935300 | 000 |
| 00841439108772 | K935300 | 000 |
| 00841439108796 | K935300 | 000 |
| 00841439108833 | K935300 | 000 |
| 00841439108840 | K935300 | 000 |
| 00841439108857 | K935300 | 000 |
| 00841439108819 | K935300 | 000 |