The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Ontex And Others Proprietary Names.
| Device ID | K132208 |
| 510k Number | K132208 |
| Device Name: | ONTEX AND OTHERS PROPRIETARY NAMES |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | ONTEX BVBA PRINSESSEGRACHT 20 The Hague, NL 2514ap |
| Contact | Rachel Paul |
| Correspondent | Rachel Paul ONTEX BVBA PRINSESSEGRACHT 20 The Hague, NL 2514ap |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-16 |
| Decision Date | 2014-04-10 |
| Summary: | summary |