FDA 510(k) Application Details - K250735

Device Classification Name	More FDA Info for this Device
510(K) Number	K250735
Device Name	Dental Barrier and Sleeves
Applicant	Fomed Industries, Inc. 20 Han sha Road HouHu District Qian Jing City 433115 CN Other 510(k) Applications for this Company
Contact	Xing He 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	03/11/2025
Decision Date	06/10/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review