FDA 510(k) Application Details - K152157

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K152157
Device Name	Device, Vascular, For Promoting Embolization
Applicant	BIOCOMPATIBLES UK LTD Chapman House, Farnham Business Park, Weydon Lane Farnham GU9 8QL GB Other 510(k) Applications for this Company
Contact	April Kent Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2015
Decision Date	12/11/2015
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