FDA 510(k) Application Details - K242105

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K242105
Device Name	Tampon, Menstrual, Unscented
Applicant	Essity Higiene Y Salud Mexico. S.A. DE C.V. Avenida Santa Fe No. 428. Torre II, Piso 12 Colonia Santa Fe Cuajimalpa, Alcaldia Cuajimalpa De Morelos Cuidad De Mexico 05348 MX Other 510(k) Applications for this Company
Contact	Sean Anderson Other 510(k) Applications for this Contact
Regulation Number	884.5470   More FDA Info for this Regulation Number
Classification Product Code	HEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2024
Decision Date	04/01/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review