FDA 510(k) Application Details - K132464

Device Classification Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene   More FDA Info for this Device
510(K) Number	K132464
Device Name	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant	OMNIA SPA VIA SARAGAT 5 IMOLA, BO 40026 IT Other 510(k) Applications for this Company
Contact	MARCO MANDUCHI 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	08/07/2013
Decision Date	02/12/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review