FDA 510(k) Application Details - K101000

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K101000
Device Name	Mask, Surgical
Applicant	WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD PENNINGTON, NJ 08534 US Other 510(k) Applications for this Company
Contact	CHENGYU SHEN 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	04/12/2010
Decision Date	08/09/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review