The following data is part of a premarket notification filed by Cotton High Tech S.l. with the FDA for Cohitech Non Applicator Organic Cotton Tampons;cohitech Compact Applicator Organic Cotton Tampons.
| Device ID | K152284 |
| 510k Number | K152284 |
| Device Name: | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | COTTON HIGH TECH S.L. Colonia La Rabeia S/n Barcelona, ES 08660 |
| Contact | Anna Garcia |
| Correspondent | Anna Garcia COTTON HIGH TECH S.L. Colonia La Rabeia S/n Barcelona, 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 | 2015-08-12 |
| Decision Date | 2015-12-04 |
| Summary: | summary |