FDA 510(k) Application Details - K111195

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K111195
Device Name	Staple, Implantable
Applicant	ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. CINCINNATI, OH 45242-2839 US Other 510(k) Applications for this Company
Contact	DENNIS HAHN 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	04/28/2011
Decision Date	08/03/2011
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