FDA 510(k) Application Details - K973652

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K973652
Device Name	Clip, Implantable
Applicant	SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 MIAMI, FL 33126 US Other 510(k) Applications for this Company
Contact	STEPHEN CHAKOFF 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	09/25/1997
Decision Date	03/27/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review