FDA 510(k) Application Details - K181940

Device Classification Name	More FDA Info for this Device
510(K) Number	K181940
Device Name	GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
Applicant	W. L. Gore & Associates, Inc. 301 Airport Road Elkton, MD 21922 US Other 510(k) Applications for this Company
Contact	Michael J. Titus Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2018
Decision Date	08/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review