FDA 510(k) Application Details - K971588

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K971588
Device Name	Clip, Implantable
Applicant	ELECTIVE VASCULAR INTERVENTION INC. (EVI) 2108 BLACKWOOD DR. WALNUT CREEK, CA 94596 US Other 510(k) Applications for this Company
Contact	MICHAEL A DANIEL Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	FZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/1997
Decision Date	10/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review