FDA 510(k) Application Details - K242435

Device Classification Name	More FDA Info for this Device
510(K) Number	K242435
Device Name	Dental Barrier and Sleeves
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	More FDA Info for this Regulation Number
Classification Product Code	PEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2024
Decision Date	10/18/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review