FDA 510(k) Application Details - K211519

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K211519
Device Name	Tampon, Menstrual, Unscented
Applicant	Cycle, LLC 1927 Washington Avenue Santa Monica, CA 90403 US Other 510(k) Applications for this Company
Contact	Jessica Samson 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	05/17/2021
Decision Date	08/13/2021
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