FDA 510(k) Application Details - K080178

Device Classification Name	Valvulotome   More FDA Info for this Device
510(K) Number	K080178
Device Name	Valvulotome
Applicant	KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77071-3404 US Other 510(k) Applications for this Company
Contact	J. HARVEY KNAUSS Other 510(k) Applications for this Contact
Regulation Number	870.4885   More FDA Info for this Regulation Number
Classification Product Code	MGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2008
Decision Date	07/28/2008
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