FDA 510(k) Application Details - K171039

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K171039
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	Assut Europe S.p.A. Zona Industriale Magliano dei Marsi 67062 IT Other 510(k) Applications for this Company
Contact	Gloria Aggio Other 510(k) Applications for this Contact
Regulation Number	878.5010   More FDA Info for this Regulation Number
Classification Product Code	GAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2017
Decision Date	08/29/2017
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