The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Ontex Unscented Tampons With Colored Plastic Applicators.
| Device ID | K142786 |
| 510k Number | K142786 |
| Device Name: | Ontex Unscented Tampons With Colored Plastic Applicators |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ONTEX BVBA 5 Genthof Buggenhout, BE 9255 |
| Contact | Henri Lesage |
| Correspondent | Rachel Paul Emergo Europe Consulting Prinsessegracht 20 The Hague, NL 2514 Ap |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2015-06-23 |
| Summary: | summary |