FDA 510(k) Application Details - K111559

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K111559
Device Name	Mask, Surgical
Applicant	SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. P.O. BOX 237-023 SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	06/06/2011
Decision Date	09/16/2011
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