FDA 510(k) Application Details - K083508

Device Classification Name	More FDA Info for this Device
510(K) Number	K083508
Device Name	SWABCAP
Applicant	EXCELSIOR MEDICAL CORP. 4 INNOVATION DRIVE DUNDAS, ON L2H 7P3 CA Other 510(k) Applications for this Company
Contact	ROSHANA AHMED Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2008
Decision Date	04/28/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review