FDA 510(k) Application Details - K182142

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K182142
Device Name	Tampon, Menstrual, Unscented
Applicant	Jiangsu YOAI Technology co., Ltd. Building No.3, No.33 Jing You Road, Jiangning District Nanjing 211100 CN Other 510(k) Applications for this Company
Contact	Huan Wang 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	08/07/2018
Decision Date	08/28/2019
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