The following data is part of a premarket notification filed by Ranir Llc with the FDA for Rest Assured Nite Protector.
| Device ID | K063229 |
| 510k Number | K063229 |
| Device Name: | REST ASSURED NITE PROTECTOR |
| Classification | Mouthguard, Over-the-counter |
| Applicant | RANIR LLC 900 FIFTH THIRD CENTER 111 LYON STREET N.W. Grand Rapids, MI 49503 |
| Contact | Christopher Predko |
| Correspondent | Christopher Predko RANIR LLC 900 FIFTH THIRD CENTER 111 LYON STREET N.W. Grand Rapids, MI 49503 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-25 |
| Decision Date | 2006-12-19 |
| Summary: | summary |