FDA 510(k) Application Details - K191361

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K191361
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	DemeTECH Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 US Other 510(k) Applications for this Company
Contact	Tracy Chadwrick Other 510(k) Applications for this Contact
Regulation Number	878.4840   More FDA Info for this Regulation Number
Classification Product Code	NEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2019
Decision Date	11/07/2019
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