The following data is part of a premarket notification filed by Ontex International Nv with the FDA for Ontex Tampon (unscented).
| Device ID | K090819 |
| 510k Number | K090819 |
| Device Name: | ONTEX TAMPON (UNSCENTED) |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ONTEX INTERNATIONAL NV 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Neal Kober |
| Correspondent | Neal Kober ONTEX INTERNATIONAL NV 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-12-23 |
| Summary: | summary |