FDA 510(k) Application Details - K190484

Device Classification Name	More FDA Info for this Device
510(K) Number	K190484
Device Name	BH Medical Dental Barrier Sleeves and Barrier Film
Applicant	BH Medical Products Co., Ltd. No.90 Shenjiang Villagers' group, Zhangjiacunwei, Xilin Street, Zhonglou District Changzhou 213024 CN Other 510(k) Applications for this Company
Contact	Xiaohua TAO 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	02/27/2019
Decision Date	09/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review