FDA 510(k) Application Details - K140415

Device Classification Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene   More FDA Info for this Device
510(K) Number	K140415
Device Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant	RIVERPOINT MEDICAL 825 NE 25TH AVE. PORTLAND, OR 97232 US Other 510(k) Applications for this Company
Contact	DOUGLAS ROWLEY Other 510(k) Applications for this Contact
Regulation Number	878.5035   More FDA Info for this Regulation Number
Classification Product Code	NBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2014
Decision Date	03/26/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review