FDA 510(k) Application Details - K063844

Device Classification Name	Stabilizer, Heart, Non-Compression, Reprocessed   More FDA Info for this Device
510(K) Number	K063844
Device Name	Stabilizer, Heart, Non-Compression, Reprocessed
Applicant	STERILMED, INC. 11140 73RD AVE. NORTH MINNEAPOLIS, MN 55369 US Other 510(k) Applications for this Company
Contact	DENNIS TOUSSAINT Other 510(k) Applications for this Contact
Regulation Number	870.4500   More FDA Info for this Regulation Number
Classification Product Code	NQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2006
Decision Date	03/15/2007
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