FDA 510(k) Application Details - K100506

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K100506
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	TELEFLEX MEDICAL 5307 95TH AVENUE KENOSHA, WI 53144 US Other 510(k) Applications for this Company
Contact	VALERIE FOLLOWELL 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	02/22/2010
Decision Date	03/10/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review