FDA 510(k) Application Details - K000855

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K000855
Device Name	Filter, Intravascular, Cardiovascular
Applicant	COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 BLOOMINGTON, IN 47402 US Other 510(k) Applications for this Company
Contact	MARY GOSSARD Other 510(k) Applications for this Contact
Regulation Number	870.3375   More FDA Info for this Regulation Number
Classification Product Code	DTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2000
Decision Date	10/18/2000
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