The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Med-tec Redi-foam.
| Device ID | K951808 |
| 510k Number | K951808 |
| Device Name: | MED-TEC REDI-FOAM |
| 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 | 1995-04-19 |
| Decision Date | 1995-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439110928 | K951808 | 000 |
| 00841439110911 | K951808 | 000 |
| 00841439110904 | K951808 | 000 |