FDA 510(k) Application Details - K091084

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K091084
Device Name	Tampon, Menstrual, Unscented
Applicant	COTTON HIGH TECH SL CTRA NAVAS A PRATS DE LLUCANES KM 1,5 GAIA BARCELONA 08679 ES Other 510(k) Applications for this Company
Contact	ELENA GOMEZ 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	04/15/2009
Decision Date	04/29/2009
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