The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Unscented W Long Plastic And Cardboard Applicator Tampons.
| Device ID | K191666 |
| 510k Number | K191666 |
| Device Name: | Unscented W Long Plastic And Cardboard Applicator Tampons |
| 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 2514ap |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-21 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08401173287618 | K191666 | 000 |
| 08401173287472 | K191666 | 000 |