FDA 510(k) Application Details - K151170

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K151170
Device Name	Tampon, Menstrual, Unscented
Applicant	TOSAMA D.O.O. SARANOVICEVA CESTA 35 VIR VIR, DOMZALE 1230 SI Other 510(k) Applications for this Company
Contact	MARJETKA KRALJ KUNCIC 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	05/01/2015
Decision Date	07/02/2015
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	Y
Expedited Review