FDA 510(k) Application Details - K091016

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K091016
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN 60 Middletown Ave North Haven, CT 06473 US Other 510(k) Applications for this Company
Contact	TIM M LOHNES 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	04/09/2009
Decision Date	05/04/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review