FDA 510(k) Application Details - K110076

Device Classification Name	More FDA Info for this Device
510(K) Number	K110076
Device Name	REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
Applicant	STERILMED, INC. 11400 73RD AVE. NORTH MAPLE GROVE, MN 55369-5562 US Other 510(k) Applications for this Company
Contact	GARRETT AHLBORG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2011
Decision Date	08/18/2011
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