FDA 510(k) Application Details - K093253

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K093253
Device Name	Staple, Implantable
Applicant	SAFESTITCH LLC 8282 SHADOW WOOD BLVD CORAL SPRINGS, FL 33071 US Other 510(k) Applications for this Company
Contact	STEWART DAVIS 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	10/16/2009
Decision Date	11/12/2009
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