FDA 510(k) Application Details - K191773

Device Classification Name	More FDA Info for this Device
510(K) Number	K191773
Device Name	GORE BIO-A Tissue Reinforcement
Applicant	W.L. Gore & Associates, Inc. 301 Airport Road Elkton, MD 21921 US Other 510(k) Applications for this Company
Contact	Barbara L. Smith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2019
Decision Date	07/31/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review