FDA 510(k) Application Details - K103052

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K103052
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Covidien LLC 60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473 US Other 510(k) Applications for this Company
Contact	JENNIFER BRENNAN Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2010
Decision Date	11/10/2010
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