FDA 510(k) Application Details - K233918

Device Classification Name	More FDA Info for this Device
510(K) Number	K233918
Device Name	Dental Barrier and Sleeves
Applicant	Yongqing Huaguan Dental Instruments Factory Intersection Of Ronghua Road And Siwei Street Yongqing Industrial Area Langfang CN Other 510(k) Applications for this Company
Contact	ZengYan Wu 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	12/13/2023
Decision Date	05/09/2024
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