FDA 510(k) Application Details - K090932

Device Classification Name	More FDA Info for this Device
510(K) Number	K090932
Device Name	NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000
Applicant	NEXGEN MEDICAL SYSTEMS, INC. 10471 DOUBLE R BLVD. SUITE C RENO, NV 89521 US Other 510(k) Applications for this Company
Contact	JOHN KUCHARCZYK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2009
Decision Date	09/24/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review