FDA 510(k) Application Details - K070036

Device Classification Name	Stabilizer, Heart, Non-Compression, Reprocessed   More FDA Info for this Device
510(K) Number	K070036
Device Name	Stabilizer, Heart, Non-Compression, Reprocessed
Applicant	ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. PHOENIX, AZ 85044 US Other 510(k) Applications for this Company
Contact	KATIE BRAY 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	01/03/2007
Decision Date	08/17/2007
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