FDA 510(k) Application Details - K980937

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K980937
Device Name	Device, Counter-Pulsating, External
Applicant	NICORE EQUIPMENT & LEASING, INC. 1625 K STREET, NW, SUITE 1000 WASHINGTON, DC 20006-1604 US Other 510(k) Applications for this Company
Contact	MICHAEL G FARROW 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	03/12/1998
Decision Date	09/15/2000
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