Cohitech Organic Cotton Non-Applicator Cottonlock Tampons

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 Organic Cotton Non-applicator Cottonlock Tampons.

Pre-market Notification Details

Device IDK211775
510k NumberK211775
Device Name:Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
ClassificationTampon, Menstrual, Unscented
Applicant Cotton High Tech S.L. Colònia La Rabeia, S/N Balsareny,  ES 08660
ContactMíriam Carrero
CorrespondentMíriam Carrero
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 Received2021-06-09
Decision Date2021-10-22

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