FDA 510(k) Application Details - K173644

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K173644
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	Dura Tap LLC 208 Upland Way Wayne, PA 19087 US Other 510(k) Applications for this Company
Contact	Ann R. 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	11/27/2017
Decision Date	02/15/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review