FDA 510(k) Application Details - K100090

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K100090
Device Name	Clip, Implantable
Applicant	GENICON 6869 STAPOINT CT., SUITE 114 WINTER PARK, FL 32792 US Other 510(k) Applications for this Company
Contact	GARY HABERLAND 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	01/12/2010
Decision Date	02/02/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review