FDA 510(k) Application Details - K201003

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K201003
Device Name	Tampon, Menstrual, Unscented
Applicant	Calla Lily Personal Care, Ltd. 10 Rose &Crown Yard London SW1Y 6RE GB Other 510(k) Applications for this Company
Contact	Shaun Knights 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	04/16/2020
Decision Date	12/07/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review