FDA 510(k) Application Details - K161737

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K161737
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	MYCO MEDICAL 158 TOWERVIEW COURT CARY, NC 27513 US Other 510(k) Applications for this Company
Contact	Sanjiv Kumar 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	06/23/2016
Decision Date	03/02/2017
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