FDA 510(k) Application Details - K132208

Device Classification Name	Tampon, Menstrual, Scented, Deodorized   More FDA Info for this Device
510(K) Number	K132208
Device Name	Tampon, Menstrual, Scented, Deodorized
Applicant	ONTEX BVBA PRINSESSEGRACHT 20 THE HAGUE 2514AP NL Other 510(k) Applications for this Company
Contact	RACHEL PAUL Other 510(k) Applications for this Contact
Regulation Number	884.5460   More FDA Info for this Regulation Number
Classification Product Code	HIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2013
Decision Date	04/10/2014
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