The following data is part of a premarket notification filed by Oravanosa, Llc with the FDA for Oravan Herbst.
| Device ID | K152159 |
| 510k Number | K152159 |
| Device Name: | Oravan Herbst |
| Classification | Device, Anti-snoring |
| Applicant | OravanOSA, LLC 769 Northfield Avenue, Suite 160 West Orange, NJ 07052 |
| Contact | Deborah Stein |
| Correspondent | Deborah Stein OravanOSA, LLC 769 Northfield Avenue, Suite 160 West Orange, NJ 07052 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-10-29 |
| Summary: | summary |