The following data is part of a premarket notification filed by Ranir/dcp Corp. with the FDA for Ranir Plax Rx.
| Device ID | K935906 |
| 510k Number | K935906 |
| Device Name: | RANIR PLAX RX |
| Classification | Mirror, Mouth |
| Applicant | RANIR/DCP CORP. P.O. BOX 8547 Grand Rapids, MI 49518 |
| Contact | Anne M Armstrong |
| Correspondent | Anne M Armstrong RANIR/DCP CORP. P.O. BOX 8547 Grand Rapids, MI 49518 |
| Product Code | EAX |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-10 |
| Decision Date | 1994-09-02 |