FDA 510(k) Application Details - K053188

Device Classification Name	Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed   More FDA Info for this Device
510(K) Number	K053188
Device Name	Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Applicant	STERILMED, INC. 11400 73RD AVE. NORTH MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	BRUCE R LESTER Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	NKU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2005
Decision Date	05/04/2006
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