The following data is part of a premarket notification filed by Rhondium, Ltd with the FDA for L- Ovc.
| Device ID | K162677 |
| 510k Number | K162677 |
| Device Name: | L- OVC |
| Classification | Powder, Porcelain |
| Applicant | Rhondium, Ltd 4 Sheffield Street Katikati, NZ 3129 |
| Contact | Greer Fricker |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | EIH |
| Subsequent Product Code | EBF |
| Subsequent Product Code | KLE |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2016-12-21 |
| Summary: | summary |