FDA 510(k) Application Details - K151470

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K151470
Device Name	Tampon, Menstrual, Unscented
Applicant	FIRST QUALITY HYGIENIC, INC. 121 North Road 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	06/01/2015
Decision Date	11/02/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review