The following data is part of a premarket notification filed by Oventus Manufacturing Pty Ltd with the FDA for Ovent.
| Device ID | K160234 |
| 510k Number | K160234 |
| Device Name: | OVENT |
| Classification | Device, Anti-snoring |
| Applicant | OVENTUS MANUFACTURING PTY LTD Suite 8, Level 17 - 141 Queen Street Brisbane, AU 4000 |
| Contact | Neil Anderson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351567000004 | K160234 | 000 |