FDA 510(k) Application Details - K032245

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K032245
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	ARTHREX, INC. 2885 SOUTH HORSESHOE DR. NAPLES, FL 34104 US Other 510(k) Applications for this Company
Contact	ANN WATERHOUSE 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	07/22/2003
Decision Date	01/14/2004
Decision	SESU - SE - WITH LIMITATIONS
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