FDA 510(k) Application Details - K083519

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K083519
Device Name	Staple, Implantable
Applicant	COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473 US Other 510(k) Applications for this Company
Contact	FRANK GIANELLI 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	11/26/2008
Decision Date	04/10/2009
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