FDA 510(k) Application Details - K181652

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K181652
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876-0151 US Other 510(k) Applications for this Company
Contact	Donna Marshall 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	06/22/2018
Decision Date	09/28/2018
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