FDA 510(k) Application Details - K093557

Device Classification Name	Counter, Sponge, Surgical   More FDA Info for this Device
510(K) Number	K093557
Device Name	Counter, Sponge, Surgical
Applicant	CLEARCOUNT MEDICAL SOLUTIONS 101 BELLEVUE RD., SUITE 300 PITTSBURGH, PA 15229 US Other 510(k) Applications for this Company
Contact	JEFF WOLFGONG Other 510(k) Applications for this Contact
Regulation Number	880.2740   More FDA Info for this Regulation Number
Classification Product Code	LWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2009
Decision Date	12/18/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review