FDA 510(k) Application Details - K071061

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K071061
Device Name	Staple, Implantable
Applicant	SORBX, LLC PO BOX 3614 PONTE VEDRA BEACH, FL 32004 US Other 510(k) Applications for this Company
Contact	MARY LEE WILLETS Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2007
Decision Date	05/16/2007
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