The following data is part of a premarket notification filed by Dynamic Functional Positioner, Inc. with the FDA for Dynamic Funtional Positioner.
| Device ID | K821458 |
| 510k Number | K821458 |
| Device Name: | DYNAMIC FUNTIONAL POSITIONER |
| Classification | Positioner, Tooth, Preformed |
| Applicant | DYNAMIC FUNCTIONAL POSITIONER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-07 |
| Decision Date | 1982-06-09 |