FDA 510(k) Application Details - K192557

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K192557
Device Name	Tampon, Menstrual, Unscented
Applicant	Qingdao Youjia Hygiene Technology Co., Ltd No. 778 Mingyue Road, Huangdao Zone Qingdao 266400 CN Other 510(k) Applications for this Company
Contact	Huiying Zhao 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	09/17/2019
Decision Date	02/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review