FDA 510(k) Application Details - K180625

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K180625
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	RK Manufacturing Corporation 34 Executive Drive Danbury, CT 06810 US Other 510(k) Applications for this Company
Contact	Joshua Hubbard Other 510(k) Applications for this Contact
Regulation Number	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2018
Decision Date	05/10/2018
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