FDA 510(k) Application Details - K243721

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K243721
Device Name	Wrap, Sterilization
Applicant	Wellmed Dental Medical Supply Co., Ltd 301 Zhongxin Science and Technology Building, No.64, XinÆan 2nd Road, Baoan District Shenzhen CN Other 510(k) Applications for this Company
Contact	Renxian Tang Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2024
Decision Date	04/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review