FDA 510(k) Application Details - K161877

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K161877
Device Name	Tampon, Menstrual, Unscented
Applicant	FIRST QUALITY HYGIENIC, INC. 121 NORTH RD. McElhattan, PA 17748 US Other 510(k) Applications for this Company
Contact	Melanie Leibowitz 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	07/08/2016
Decision Date	08/05/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review