The following data is part of a premarket notification filed by Cotton High Tech S.l. with the FDA for Cohitech Organic Cotton Non-applicator Cottonlock Tampons.
| Device ID | K211775 |
| 510k Number | K211775 |
| Device Name: | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Cotton High Tech S.L. Colònia La Rabeia, S/N Balsareny, ES 08660 |
| Contact | Míriam Carrero |
| Correspondent | Míriam Carrero 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 | 2021-06-09 |
| Decision Date | 2021-10-22 |