FDA 510(k) Application Details - K223883

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K223883
Device Name	Tampon, Menstrual, Unscented
Applicant	Annes Daye Ltd The Biscuit Factory, 100 Drummond Road, Bermondsey London SE16 4DG GB Other 510(k) Applications for this Company
Contact	Valentina Milanova 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	12/27/2022
Decision Date	08/18/2023
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