FDA 510(k) Application Details - K043199

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K043199
Device Name	Mask, Surgical
Applicant	HONG YA NON-WOVEN PRODUCTS CO., LTD. 3973 SCHAEFER AVE. CHINO, CA 91710 US Other 510(k) Applications for this Company
Contact	JAMES CHU 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	11/18/2004
Decision Date	02/16/2005
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