FDA 510(k) Application Details - K121510

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K121510
Device Name	Staple, Implantable
Applicant	COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 US Other 510(k) Applications for this Company
Contact	SARAH RIZK 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	05/21/2012
Decision Date	07/25/2012
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