FDA 510(k) Application Details - K100518

Device Classification Name	Dilator, Vessel, Surgical   More FDA Info for this Device
510(K) Number	K100518
Device Name	Dilator, Vessel, Surgical
Applicant	INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT SCHAUMBURG, IL 60173 US Other 510(k) Applications for this Company
Contact	MICHAEL MASSONG Other 510(k) Applications for this Contact
Regulation Number	870.4475   More FDA Info for this Regulation Number
Classification Product Code	DWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2010
Decision Date	08/31/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review