FDA 510(k) Application Details - K082258

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K082258
Device Name	Mask, Surgical
Applicant	CROSSTEX INTERNATIONAL 14605 28TH AVENUE NORTH MINNEAPOLIS, MN 55447 US Other 510(k) Applications for this Company
Contact	RICHARD M ORMSBEE 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	08/08/2008
Decision Date	10/16/2008
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