FDA 510(k) Application Details - K180167

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K180167
Device Name	Tampon, Menstrual, Unscented
Applicant	Playtex Manufacturing, Inc. 804 Walker Road Dover, DE 19904 US Other 510(k) Applications for this Company
Contact	Ludjane Fiorillo 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	01/22/2018
Decision Date	05/30/2018
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