The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Ontex And Other Proprietary Names.
| Device ID | K162746 |
| 510k Number | K162746 |
| Device Name: | Ontex And Other Proprietary Names |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ONTEX BVBA 5 Genthof Buggenhout Oost-vlaanderen, 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 | 2016-09-30 |
| Decision Date | 2017-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006387723 | K162746 | 000 |
| 00860006387716 | K162746 | 000 |
| 00860006387709 | K162746 | 000 |