FDA 510(k) Application Details - K090821

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K090821
Device Name	Staple, Implantable
Applicant	FRANKENMAN INTERNATIONAL LIMITED 1705 S. CAPITAL OF HWY SUITE 500 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	JEAN ASQUITH 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	03/26/2009
Decision Date	06/10/2009
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