FDA 510(k) Application Details - K152115

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K152115
Device Name	Device, Counter-Pulsating, External
Applicant	Stage 2 Innovations 7811 Montrose Rd Rockville, MD 20854 US Other 510(k) Applications for this Company
Contact	Richard Kotz 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	07/29/2015
Decision Date	12/17/2015
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