The following data is part of a premarket notification filed by Ranir Llc with the FDA for Grind No More Generation Ii.
| Device ID | K094020 |
| 510k Number | K094020 |
| Device Name: | GRIND NO MORE GENERATION II |
| Classification | Mouthguard, Over-the-counter |
| Applicant | RANIR LLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan 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 | 2009-12-29 |
| Decision Date | 2010-01-25 |
| Summary: | summary |