FDA 510(k) Application Details - K022078

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K022078
Device Name	Device, Counter-Pulsating, External
Applicant	SOLA MEDICAL DEVICES, LLC 3722 AVE SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND Other 510(k) Applications for this Contact
Regulation Number	870.5225   More FDA Info for this Regulation Number
Classification Product Code	DRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2002
Decision Date	01/10/2003
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