FDA 510(k) Application Details - K073096

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K073096
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	EPITEK, INC. 4801 W. 81ST STREET SUITE 105 BLOOMINGTON, MN 55437 US Other 510(k) Applications for this Company
Contact	WERNER HAMPL 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	11/01/2007
Decision Date	02/07/2008
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