FDA 510(k) Application Details - K191666

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K191666
Device Name	Tampon, Menstrual, Unscented
Applicant	ONTEX BVBA 5 Genthof Buggenhout Oost - Vlaanderen 9255 BE Other 510(k) Applications for this Company
Contact	Henri Lesage 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	06/21/2019
Decision Date	12/20/2019
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