The following data is part of a premarket notification filed by Ranir Llc with the FDA for Rest Assured Ready To Wear Nite Protector.
| Device ID | K112879 |
| 510k Number | K112879 |
| Device Name: | REST ASSURED READY TO WEAR NITE PROTECTOR |
| Classification | Mouthguard, Over-the-counter |
| Applicant | RANIR LLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Gerard J Prud'homme |
| Correspondent | Gerard J Prud'homme RANIR LLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| 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 | 2011-09-30 |
| Decision Date | 2012-01-27 |
| Summary: | summary |