FDA 510(k) Application Details - K240708

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K240708
Device Name	Tampon, Menstrual, Unscented
Applicant	Suzhou Borage Medical Technology Co., Ltd. No.9, Shiheshan Road, Dongshan Town, Wuzhong District Suzhou 215107 CN Other 510(k) Applications for this Company
Contact	Zhou Nana 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	03/15/2024
Decision Date	05/10/2024
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