FDA 510(k) Application Details - K152284

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K152284
Device Name	Tampon, Menstrual, Unscented
Applicant	COTTON HIGH TECH S.L. Colonia La Rabeia s/n Barcelona 08660 ES Other 510(k) Applications for this Company
Contact	Anna Garcia 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	08/12/2015
Decision Date	12/04/2015
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	N
Expedited Review