FDA 510(k) Application Details - K241064

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K241064
Device Name	Tampon, Menstrual, Unscented
Applicant	Shandong Intco Hygiene Products Co., Ltd. Workshop C3, No. 29, Zhangliu Road, Fangzhen Town Zhangdian District Zibo 255000 CN Other 510(k) Applications for this Company
Contact	Max Li 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	04/18/2024
Decision Date	01/10/2025
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