The following data is part of a premarket notification filed by Cotton High Tech, Sl with the FDA for Cohitech Organic Cotton Applicator Tampons Light.
| Device ID | K182813 |
| 510k Number | K182813 |
| Device Name: | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Cotton High Tech, SL Colonia La Rabeia, S/N Balsareny, ES 08660 |
| Contact | Anna Garcia Llado |
| Correspondent | Anna Garcia Llado Cotton High Tech, SL Colonia La Rabeia, S/N Balsareny, ES 08660 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-03 |
| Decision Date | 2019-03-15 |