FDA 510(k) Application Details - K173747

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K173747
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	SM ENG CO., LTD 46, Nakdong-daero 1302beon-gil Sasang-gu 46910 KR Other 510(k) Applications for this Company
Contact	Soon-Gu Lee 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	12/08/2017
Decision Date	12/21/2018
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