FDA 510(k) Application Details - K123787

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K123787
Device Name	Mask, Surgical
Applicant	JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,L 6 VANDERBLET ROAD ACTON, MA 01720 US Other 510(k) Applications for this Company
Contact	XIANGYANG SONG 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	12/10/2012
Decision Date	07/17/2013
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