The following data is part of a premarket notification filed by Cotton High Tech S.l. with the FDA for Cohitech Reusable Tampon Applicator.
| Device ID | K212479 |
| 510k Number | K212479 |
| Device Name: | Cohitech Reusable Tampon Applicator |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Cotton High Tech S.L. Colònia La Rabeia S/N Balsareny, ES 08660 |
| Contact | Anna Garcia |
| Correspondent | Anna Garcia Cotton High Tech S.L. Colònia La Rabeia S/N Balsareny, ES 08660 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-10-08 |