FDA 510(k) Application Details - K082134

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K082134
Device Name	Device, Counter-Pulsating, External
Applicant	CIRCULATOR BOOT CORP. 72 PENNSYLVANIA AVE. MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	RICHARD S DILLON 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	07/29/2008
Decision Date	05/07/2009
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