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 |