FDA 510(k) Application Details - K133070

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K133070
Device Name	Mask, Surgical
Applicant	B.H. MEDICAL PRODUCTS CO., LTD. 3500 SOUTH DUPONT HIGHWAY DOVER, DE 19901 US Other 510(k) Applications for this Company
Contact	LEON LU Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	06/22/2015
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