The following data is part of a premarket notification filed by New Jersey Snoring Solutions with the FDA for Oravan Osa.
| Device ID | K121285 |
| 510k Number | K121285 |
| Device Name: | ORAVAN OSA |
| Classification | Device, Anti-snoring |
| Applicant | NEW JERSEY SNORING SOLUTIONS 769 NORTHFIELD AVENUE SUITE 154 West Orange, NJ 07052 |
| Contact | Deborah Stein |
| Correspondent | Deborah Stein NEW JERSEY SNORING SOLUTIONS 769 NORTHFIELD AVENUE SUITE 154 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 | 2012-04-30 |
| Decision Date | 2013-03-08 |
| Summary: | summary |