Cohitech Reusable Tampon Applicator

Tampon, Menstrual, Unscented

Cotton High Tech S.L.

The following data is part of a premarket notification filed by Cotton High Tech S.l. with the FDA for Cohitech Reusable Tampon Applicator.

Pre-market Notification Details

Device IDK212479
510k NumberK212479
Device Name:Cohitech Reusable Tampon Applicator
ClassificationTampon, Menstrual, Unscented
Applicant Cotton High Tech S.L. Colònia La Rabeia S/N Balsareny,  ES 08660
ContactAnna Garcia
CorrespondentAnna Garcia
Cotton High Tech S.L. Colònia La Rabeia S/N Balsareny,  ES 08660
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-10-08

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.