FDA 510(k) Application Details - K121306

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K121306
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	ARTHOCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE AUSTIN, TX 78735 US Other 510(k) Applications for this Company
Contact	CHERYL FREDERICK 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	05/01/2012
Decision Date	07/12/2012
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