The following data is part of a premarket notification filed by Ranir Llc with the FDA for Rest Assured Extra Comfort Nite Protector.
| Device ID | K133423 |
| 510k Number | K133423 |
| Device Name: | REST ASSURED EXTRA COMFORT NITE PROTECTOR |
| Classification | Mouthguard, Over-the-counter |
| Applicant | RANIR LLC 4701 EAST PARIS AVE. S.E. Grand Rapids, MI 49512 |
| Contact | Paula Bojsen |
| Correspondent | Paula Bojsen RANIR LLC 4701 EAST PARIS AVE. S.E. Grand Rapids, MI 49512 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-08 |
| Decision Date | 2013-12-20 |
| Summary: | summary |