The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Ontex Roll Wadding Plastic Applicator Compact Size Unscented Tampons.
| Device ID | K132595 |
| 510k Number | K132595 |
| Device Name: | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| 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 | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-19 |
| Decision Date | 2014-04-23 |
| Summary: | summary |